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○ Revision History

No Revision Date Modifications

Risk Management Report

It was first created in accordance with Good Manufacturing
0 2023.06.30
Practices (KGMP) and ISO 13485 for medical devices.

Model Name ENAD

Document Number EI-RMR-02

Established date 2023.06.30

Reversion date -

Reversion Number -

Prepared by Prepared by Approved by

Name Hojin Choi Jiwoon Jeon Jinbae Park

Position Engineer Engineer QMR

Signature

Date 2023. 06. 30. 2023. 06. 30 2023. 06. 30

This is owned by AINEX Co., Ltd. It contains confidential proprietary trade secret information and
must not be copied. The document and the information it contains can be used only by the
recipient for the specific use for which it was requested. This document must be returned
immediately upon the request by AINEX Co., Ltd.

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1. Introduction
This risk management report is intended to minimize risk by identifying hazards and
minimizing and preventing the occurrence of possible harm during the entire life cycle of our
endoscopic image analysis software in accordance with ISO 14971:2019, including planning,
development, design, and production, so that all persons involved, such as handlers,
operators, or users of this product, do not suffer loss of life and property.

2. Definition of Terms

Table of contents 2.1 Accompanying document

A document accompanying a medical device that contains information for the installation, use,
and maintenance of the medical device and for the operator or user, particularly with respect to
1. Introduction the safety of the medical device.
2.2 Harm
2. Definition of Terms
Physical injury or damage to human health, or damage to property or the environment.
3. Product Description 2.3 Hazard
Potential risks
4. Risk Analysis 2.4 Hazardous situation
A condition in which people, property, or the environment are exposed to one or more hazards.
5. Risk Assessment
2.5 Intended use
6. Risk Control The intentional use of a product, process, or service in accordance with the specifications,
instructions, and information provided by the manufacturer.
7. Evaluation of Total Residual Risk Tolerance
2.6 Life-cycle
8. Risk Management Report Every stage of the medical device lifecycle, from initial development to final disposal.
2.7 manufacturer
9. Production and Post-Production
A natural or legal person who assumes full responsibility for the design, manufacture, packaging,
10. FMEA Report labeling, system assembly, or modification of a medical device before it is sold or used.
2.8 Medical device
The use, either alone or in combination, of any device, apparatus, instrument, appliance, implant,
in vitro reagent, calibrator, software, material, or other similar or related item intended by the
manufacturer for use in the human body.
2.9 Objective evidence
Data that supports the existence or truth of something.
2.10 Post-production
The product lifecycle after the design is complete and the medical device is manufactured.
For example, transportation, storage, installation, use, maintenance, repair, modification, end-of-life,
and disposal of the Product.

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2.11 Procedure 2.28 Benefit

A prescribed method for performing an act or process. A positive impact or desirable outcome of the use of a medical device on an individual's health,
2.12 Process or a positive impact on patient care or public health.
A set of interrelated or interacting activities that transform inputs into outputs. * Benefits may include clinical outcomes, patient quality of life, diagnosis-related outcomes,
2.13 Record positive impact on clinical outcomes of a diagnostic device, or positive impact on public health.
Documentation that describes the results achieved or proves the activities performed. 2.29 Reasonably foreseeable misuse
2.14 Residual risk The use of a product or system in a manner not intended by the manufacturer, but which may
Risks that remain after risk management is in place result from easily predictable human behavior.
2.15 Risk * Easily foreseeable human behavior includes all types of user behavior, including casual and
A combination of the likelihood of harm and the severity of the harm. expert users
2.16 Risk analysis * Reasonably foreseeable misuse can be intentional or unintentional.
The systematic use of available information to identify hazards and estimate risk. 2.30 State of the arts
2.17 Risk assessment The stage of development of a technological capability at a given time in relation to products,
Overall process including risk analysis and risk assessment processes, and services, based on the results of relevant integrated research in science,
2.18 Risk control technology, and experience.
The process by which decisions and actions are made to reduce or maintain risk below a * State of the art is what is currently and generally accepted as good practice in the technology
prescribed level. described herein, often referred to as "generally accepted technology".
2.19 Risk estimation
The process used to value the likelihood of harm and the severity of that harm.
2.20 Risk evaluation
The process of comparing a calculated risk to an established risk standard to determine the
acceptability of the risk.
2.21 Risk management
The systematic application of management policies, procedures, and practices to the task of
analyzing, assessing, controlling, and monitoring risk.
2.22 Risk management file
Records and other documents created by risk management
2.23 Safety
Absolutely no unacceptable risk
2.24 Severity
The magnitude of the consequences of a hazard
2.25 Top management
The person or group of people who direct and control a manufacturer from the highest position.
2.26 Use error
An act, or omission to act, that results in a different response from that intended by the
manufacturer or expected by the user of the medical device.
2.27 Verification
To verify, through objective evidence, that a specified requirement has been met.

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3. Product Description ● Category : Software

● Item name: Endoscopic image analysis software
Item name Endoscopic Image Analysis Software
● Grade : Grade 2
Product ENAD
name ● Country of manufacture : Korea
Purpose of Endoscopic image analysis software that displays areas containing abnormalities
use (ridges or depressions) in endoscopic images. 5.2 People, organizations, and dates involved in executing the risk management process
This product is a software medical device that uses artificial intelligence technology
Based on the life cycle in the early stages of product development and production, we want to identify
based on machine learning to help users read images of colon and stomach
factors in each field and manage risks in a way that can reduce them, i.e., by monitoring the product
endoscopic images by displaying shapes and alarms where ridges or depression
patterns appear. It receives real-time images of medical endoscopes used for currently developed and in the state of mass production after completion.
diagnosis in hospitals as input and displays abnormal areas where bumps or - Risk management implementation period: February 17, 2023 ~ June 29, 2023
depression patterns appear in the images.
The computer installed with the product is connected to the endoscopic device in Step Description Reference Deliverables Responsibilities
the clinical laboratory with an SDI or HDMI cable and outputs the image data on ­ Risk
the screen as it is through the capture board. When ENAD is executed while the Plan risk management ­ ISO 14971:2019 Management
image is displayed, it analyzes the image frame by frame in real time and calculates Risk activities and establish risk ­ NiDS Safety Plan Head of R&D
and displays the coordinates of the abnormal area. planning criteria for risk Information ­ Design and Head of Quality
management ­ FDA Recall, etc. development
In order to learn the image of the enlarged image rather than the normal image,
we used YOLOv5, a type of Recurrent Neural Network (RNN) and Convolutional files
Operating - Intended Use
Neural Network (CNN), a type of deep artificial neural network, for training. YOLO is ­ ISO 14971:2019
Principle - Identify safety-related
an object detection algorithm with a simple neural network that extracts and ­ Risk
characteristics
generalizes the features of an object by looking at the image at once. In object - Hazards and hazardous Management - Risk
Risk Head of R&D
detection research, which focuses on real-time image detection and classification, situations Plan Management
Analysis Head of Quality
algorithmic model training is mainly performed based on YOLOv5 to generalize Identification ­ NiDS Safety Reports
- Estimate the
images at a fast speed. YOLOv5 focuses on improving the speed and accuracy of Information
risk estimation for each
the neural network compared to the original YOLO model. It uses a powerful hazard ­ FDA Recall, etc.
backbone called CSPDarknet53 to perform effective feature extraction from input - Risk
Risk Evaluate each identified risk ­ ISO 14971:2019 Head of R&D
images, and integrates a Spatial Pyramid Pooling (SPP) module and a Path Management
Assessment factor ­ Expert Opinions Head of Quality
Aggregation Network (PAN) architecture as the detection neck. The SPP module Reports
captures contextual information at different scales to accurately detect objects of - Selecting Risk Controls - Risk
- Implementation of Risk Management
different sizes and backgrounds, and the PAN architecture effectively combines
Controls
features extracted at different scales to improve performance. The architecture of Reports Action
- Residual Risk Assessment ­ ISO 14971:2019
YOLOv5 is used as the detection head. - Risk/Benefit Analysis - Design and Implementation :
Risk ­ Expert Opinions Head of R&D
- Evaluate whether the Development Files
Control ­ Customer
Notes - control measures ­ User Manuals Verification :
new risks due to control requirements
­ Performance Quality Manager
measures
4. Risk Analysis - Validation of control Test Report
4.1 Coverage measures ­ Product

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Standards A
ISO TR 24971:2020 Annex A Characteristics
­ ISO 14971:2019 N/A
Evaluation
- Assessing Overall Residual ­ Risk - Risk contact, or insertion, and the duration and frequency
of Total
Risk Head of R&D of the contact.
Residual Management Management
- Risk/Benefit Analysis Head of Quality
Risk Plans Reports 4 What materials or components were used for, with, N/A N/A
- Risk Management Review
Tolerance
­ Expert Opinions or in contact with the medical device?
­ Risk Factors to be reviewed include
Management - Risk - Compatibility with related materials
Production Plans and Management - Compatibility with cells or body fluids
- Collection of production,
and Head of R&D - Are its safety-related properties known?
post-production information complaint Reports
Post-Produ Head of Quality - Was the device made using materials derived from
and review of information. procedures, etc. - Management
ction
animals?
Related Review Report
Procedures 5 Is the energy being supplied to or extracted from the N/A N/A
patient? Factors to consider include the following This product does not provide energy to the
5.3 Identify characteristics related to the intended use and safety of medical devices - The form of energy being transferred patient or extract energy from the patient.
- Its control, quality, quantity, intensity, and duration
A
ISO TR 24971:2020 Annex A Characteristics - Is the level of energy higher than currently used in
N/A
similar devices?
1. What is the intended use and how will the - Software used to detect abnormalities in
medical device be used? What is the role of the endoscopic images and display them as
medical device in relation to 6 Is the substance being supplied to or extracted from N/A No substance is supplied or extracted from
outlines, colors, or indicators, or to
- Diagnose, prevent, monitor, treat, or alleviate a the patient? the patient.
A automatically indicate the likelihood of
disease or condition
N/A the presence of disease, the severity of Factors to consider include
- Compensate for an injury or disability
- Substitute or modify the human body, or regulate N/A - Whether the substance is being supplied or extracted
disease, or the condition of disease, to
pregnancy assist healthcare providers in making - whether it is a single substance or a range of
A substances
diagnostic decisions.
- What is the desirable usage (e.g., number of N/A
- Medical image retrieval, processing, and - Maximum and minimum transfer rates and their
patients)? A
- Is the medical device intended to sustain or transmission control
support life? - Processing such as repair in case of
- Does the medical device require special 7 Does a medical device intended for reuse, N/A N/A
failure can always be done only by the
intervention when it fails? transfusion, or implantation process biological
manufacturer.
material?
.2 Is the device intended for implantation in the body? N/A N/A, not related to in vivo implantation. Factors to consider should include the form of
Factors to consider include the location of the implant, processing and the substance being processed.
characteristics of the patient population, age, weight, (For example, processing for automated transfusion,
physical activity, effects of aging on the implant, life dialysis, blood components, or cell therapy).
expectancy of the implant, and retrievability of the
implant. 8 Are medical devices supplied sterilized, are users N/A This product is software, so N/A.
required to sterilize them, or are other microbiological
[Link] the medical device intended to come into N/A N/A controls available?
contact with the patient or another person?
Factors to review include the following
Factors to consider include the nature of the
intended contact, such as surface contact, invasive - Whether the device is packaged as single-use or

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A A
ISO TR 24971:2020 Annex A Characteristics ISO TR 24971:2020 Annex A Characteristics
N/A N/A
reusable. involved; identifying any issues that may arise with
- Expiration date issues such interactions; and determining if the patient is
- Limitations on the number of reuse cycles appropriate for such therapy.
- How the product is sterilized
14 Are there any unnecessary outputs of energy or N/A A device with no energy output.
- The effects of other sterilization methods not
matter?
intended by the manufacturer.
Energy-related factors to consider include noise and
9 Are users required to regularly clean and sterilize the N/A N/A for non-human contact products. vibration, heat, radiant heat (including ionizing,
device? non-ionizing, ultraviolet/visible/infrared), contact air
Factors to consider include the form of cleaning, the temperature, leakage current, and electrical or
sanitizer to be used, and whether there are any magnetic fields.
restrictions on the number of cleaning cycles. The Material-related factors to be considered include
design of a medical device can affect the effectiveness materials used in manufacturing, cleaning, or testing
of routine cleaning and sterilization. You should also that, if left in the product, could have unintended
consider the impact of cleaning and sanitizing solvents physiological effects.
on the safety or functionality of the device. Immersion factors include the release of chemicals,
10 Is the device intended to change the patient N/A waste, and bodily fluids.
N/A
experience? 15 Is the medical device environmentally sensitive? N/A N/A
Factors to consider include Factors to consider include the operating,
- Temperature transportation, and storage environments. These
- Humidity include sensitivity to changes in light, temperature,
- Gas composition of the atmosphere humidity, vibration, liquid spills, electrical and cold air
- Pressure supply, and electromagnetic interference.
- Lighting
11. Is it a measuring device? N/A 16 Does the device have an environmental impact? N/A ­ This product has no environmental impact
N/A
Factors to consider include the accuracy and Factors to consider include
precision of the measured variables and results. - Impact on electricity and cold air supply
The need for calibration and maintenance should - Release of toxins
also be considered. - Generation of electromagnetic waves
12 Is it an interpretive medical device? N/A N/A 17 Are there any mandatory consumer goods or A - This product must be used with a PC.
Factors to consider include whether the conclusions accessories associated with the medical device?
presented by the medical device are derived from the Factors to consider include the specifications of such
information input or obtained, the algorithms used, and consumer goods or accessories and whether any
the limits of confidence. Special attention should be restrictions are placed on the user in selecting them.
paid to whether any unintended information or
18 Is the device in need of maintenance, inspection, or
algorithms have been applied.
calibration?
13 Is the device intended to be used in conjunction with N/A ­ Not for use in conjunction with any other d A - If a malfunction occurs, it must be repaired
Factors to consider include the following
another device, drug, or other medical technology? evice, drug, or medical technology. by the manufacturer.
- Does it require maintenance or adjustment by an
Factors to consider include determining if there are A - A maintenance installation package from th
operator, user, or specialist?
other devices, drugs, or other medical technologies e manufacturer is required.
- Are special materials or equipment required to

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A A
ISO TR 24971:2020 Annex A Characteristics ISO TR 24971:2020 Annex A Characteristics
N/A N/A
perform normal maintenance or adjustments? - 26 Is it a single-use medical device? N/A ­ This product is not a single-use medical de
Factors to consider include the following Is the device vice.
19. Is it a medical device with software? A ­ This product cannot be installed, verified,
automatically discarded after use? Is it clear that the
Among the factors to consider are whether the modified, or replaced with a USB that store
s software; verification, modification, and r device has been used?
software is intended to be installed, replaced, verified,
modified, and replaced by an operator, user, or eplacement must be performed by a profes 27 Is the medical device subject to safe withdrawal of N/A ­ This product is stored on a USB and does
sional. not require any disposal method.
specialist. use and disposal?
Factors to consider include the waste generated during
20. Does the medical device allow access to A ­ This product is a USB that stores the softw
are. disposal of the medical device itself.
information?
For example, does it contain poisons or hazardous
Factors to consider include accessible internet ports,
materials?
USB ports, serial ports, and removable hard drives.
Or is the material recyclable?
21. Does the medical device store data that is critical to A If the medical device stores data, consider the proper
patient care? handling and security of the stored data, including data
Factors to consider include the potential for data to be removal and retention.
modified or compromised, unauthorized access to the
28 Does the medical device require special training A ­ This product requires prior knowledge and
data, and patient outcomes.
or skills to install and use? training in the handling of medical imaging
[Link] the medical device have a limited shelf life? N/A N/A Factors to consider include the complexity and systems.
Factors to consider include whether the medical novelty of the medical device and the knowledge,
device can deteriorate over time, storage conditions skills, and abilities of the person installing,
and the impact of primary packaging, notification of maintaining, or using the medical device. This may
the expiration date (by label or indicator), availability include training, education, competency assessment,
of use after the expiration date, and disposal of the certification, or qualification.
expired medical device.
29 How do I provide information for safe use?
23. Is the medical device intended to have a delayed N/A Not applicable because it is not a device for Factors to consider include the following
or long-term effect? delayed or long-term use to have an effect, but - Will information be provided directly from the - Provide details about the maintenance and
manufacturer to the end user, or will it require the A safety of the equipment in the user manual.
Factors to consider include ergonomic effects and rather assumes temporary use.
cumulative effects. Examples include salt water involvement of an installer, assistant, healthcare
pumps that rust over time, mechanical fatigue, loss professional, or pharmacist, and will training be
of straps and attachments, vibration effects, fraying required? A
or peeling labels, and material degradation over - Whether the trial run, transfer to end users, and - Ensure that testing operations are handled
time. installation can be accomplished by non-technical by persons with minimal training in handling
personnel. the product.
24 Is the medical device subject to any mechanical N/A N/A
- Based on the predicted life of the device, is there a N/A - Not applicable
forces?
need for retraining or reauthorization of operators or
Factors to consider include whether the forces
service personnel?
governing the device are under the control of the user
or controlled by interaction with other people. 30. Should a new manufacturing process be A ­ Unlike conventional medical device manufa
established or introduced? cturing, this product is produced by storing
25 What determines the lifespan of a medical device? N/A ­ As a software product, it can be used conti
Factors to consider include new technology or new it in a program computer.
Factors to consider include aging and battery drain. nuously on any PC that meets or exceeds o
ur specifications. scale of production.

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A A
ISO TR 24971:2020 Annex A Characteristics ISO TR 24971:2020 Annex A Characteristics
N/A N/A
[Link] the successful utilization of medical devices A ­ This is a program that has a significant imp and the accessibility of important information.
rely heavily on human factors such as user 31.6 Is the medical device controlled by a manual? A Refer to the user manual
act on the efficiency of your work based on it
interface? s user interface. Factors to be considered include the complexity and
number of steps, identification of states, setting
31.1 Are user interface design features contributing to A ­ The product includes automatic algorithms locations, navigation methods, number of steps per
misuse? and more, and displays appropriate warnings
action, clarity of links and memory issues, importance
Factors to consider are characteristics of the user when it fails.
of controls in relation to accessibility to the self, and
interface design that contribute to misuse. impact of deviations from specific operating
Examples of interface design characteristics include procedures.
the following Controls and indicators, symbols used, 31.7 Does the successful use of a medical device A For use by medical professionals only
ergonomics, physical design and layout, operational depend on the user's knowledge, skills, and abilities?
taxonomy, menus for computerized controls, visibility Factors to consider include
of warning statements, audibility of alarms, - User, mental and physical abilities, skills, and training
standardization of color coding, etc. - The use environment, ergonomics, and installation

31.2 Is the medical device used in a distracting N/A ­ This product is intended for diagnostic use requirements

environment that could lead to errors of use? in hospitals and is not intended for use in d - The user's ability to control or influence the use of the

- Consequences of misuse istracted environments. medical device

- Whether the distraction is routine - Personal characteristics of the intended user that

- Whether the user could be agitated by uncommon may affect their ability to successfully interact with the

distractions medical device

31.8 Is the medical device intended for use by persons N/A N/A
31.3 Is the part or accessory connected to a medical N/A N/A requiring nursing care?
device? Factors to be considered include the user, their mental
Factors to consider include the potential for incorrect and physical abilities, skills and training, ergonomics,
connections, similarity to connections to other environment of use, installation requirements, and the
products, connection strength, feedback on connection patient's ability to influence or control the use of the
completeness, over- and under-tightening, etc. medical device. Special attention should be paid to

31.4 Does the medical device have a control interface? N/A N/A people with special needs, such as people with

Considerations include spacing, coding, classification disabilities, the elderly, and children.

grouping, mapping, mode of feedback, blunders, slips, 31.9 Can the user interface be used to initiate user N/A N/A
control differentiation, visibility, direction of activation behavior?
or change, whether controls are continuous or Factors to be considered include the likelihood of
discrete, and reversibility of settings or actions. the user initiating a deliberate action to enter a
behavioral control state, and whether the patient is

31.5 Is it a medical device that displays information? aware of and prepared for that state because it
A ­ Software used to detect and store polyps o
increases the patient's risk.
n colonoscopy images Medical Aids
Factors to consider include visibility under different
conditions, orientation, the user's visual abilities, the Does the medical device use an alarm system? A ­ This product includes the ability to display er
number of people and their views, the clarity of the Factors to be considered include the risk of false ror messages to users for incorrect access.
information provided, the classification of units, colors, alarms, missing alarms, unconnected alarm systems,

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A 5.4 Identifying risk factors

ISO TR 24971:2020 Annex A Characteristics
N/A
unreliable remote alarm systems, and the ability of
Potential
A
Risk Factors Risk Factors Possible harm to users ID No.
medical personnel to understand how the alarm N/A
Normal Defective
system works. Guidance on alarm systems is
provided in IEC 60601-1-8 [26].
A. Energy Hazards
33 How can medical devices be intentionally misused? Power Voltage N/A - - - -
N/A ­ You must enter your password before usin
Factors to consider include misuse of connectors, g this product. External Leakage
N/A - - - -
disabling alarms or safeguards, and neglect of Electrom Current
Leakag
maintenance by the manufacturer. agne tic Protective Ground
e N/A - - - -
34 Is the device mobile or portable? energy Leakage Current
N/A N/A Current
Considerations include the required grips, handles, Patient Leakage
N/A - - - -
wheels, brakes, mechanical stability, and durability. Current
35 Is the use of the medical device dependent on an Electric Fields N/A - - - -
N/A N/A
essential performance? Magnetic Fields N/A - - - -
Factors to consider include, for example, the nature of Ionizing radiation N/A - - - -
the output of a life support device or the operation of
Radiant Energy
Non-ionizing radiation N/A - - - -
an alarm system.
High temperature N/A - - - -
36. Is the medical device autonomous? N/A N/A Thermal energy
Factors to consider include Low temperature N/A - - - -

- The user's perception of an error, alarm, or failure of Product damage due to

Gravity A  -
product drops
R01
the medical device, which is the degree of autonomy.
Descend N/A - - - -
- The user's perception of when intervention is required
for an autonomously performed action floating matters N/A - - - -

- The user's ability to intervene or interrupt Vibration N/A - - - -

autonomously performed actions
- The user's ability to select and perform appropriate
Energy Storage N/A - - - -

corrective actions. For further guidance on medical Moving Objects N/A - - - -

devices with a degree of autonomy, see IEC TR Physical Energy Distortion, shear stress,
N/A - - - -
60601-4-1. and tension
37. Does the medical device generate outputs that are N/A N/A Patient movement and
N/A - - - -
used as inputs when determining clinical actions? position
Factors to consider include whether inaccurate or Ultrasonic Energy N/A - - - -
delayed outputs could pose a supervisory indirect
Low Frequency Energy N/A - - - -
hazard to the patient (e.g., delay or omission of
Acoustics N/A - - - -
treatment for a patient due to an incorrect diagnosis).
Hyperbaric fluid
See Appendix H for guidance on in vitro diagnostic N/A - - - -
injection
medical devices.
B. Biological and Chemical Hazards
Bacteria N/A - - - -

Biological Objects Virus N/A - - - -

Other pathogens N/A - - - -

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Potential Potential
A A
Risk Factors Risk Factors Possible harm to users ID No. Risk Factors Risk Factors Possible harm to users ID No.
N/A N/A
Normal Defective Normal Defective
Reinfection or Routine violations N/A - - - -
N/A - - - -
cross-infection D. Informational Risk Factors
Acid or Alkali N/A - - - - Incomplete usage
A   Incorrect training R06
descriptions
residue N/A - - - -
Incomplete description
Contaminants N/A - - - - Missing descriptions of
of functional A  -
device characteristics
R07
Adducts Labels characteristics
N/A - - - -
or auxiliaries Inadequate specification Data elements unsuitable
A  - R08
for the intended use
Chemicals Cleaning, disinfection for intended use
N/A - - - - Inadequate disclosure
or test solvents A  - Errors in product limitations R09
of limitations
Poor specification of
Descent products N/A - - - -
components used with N/A - - - -
Medical gases N/A - - - - the medical device
O p er a t i ng
Poor specification of Product failure due to
Anesthesia products N/A - - - -
instructions A  - failure to perform a R10
pre-use inspection pre-use inspection
Biological Allergenicity/excitement N/A - - - -
Overly complex
N/A - - - -
Compatibility Pyrogenic/toxic, etc. N/A - - - - operating instructions
C. Misuse Hazards
Adverse events N/A - - - -
Incorrect or
inappropriate Incorrect or inappropriate Warnings Hazards associated with
A  - output or functionality due R02
deliverables or to user misbehavior the reuse of single-use N/A - - - -

functionality medical devices

Unauthorized maintenance
Service and maintenance specifications A   attempts by R11
Function Incorrect actions N/A - - - - non-professionals
F. Production Process Hazards
Sending incorrect Use purchased goods that
N/A - - - Improper Inspection of do not conform to specified
information A -  R12
Loss or degradation of Purchased Goods purchased goods
Inability to store data due
A - 
to insufficient capacity
R03 requirements
functionality Improper assembly
Deletion of information or N/A - -
Lack of attention A  - images due to user R04 Production process
carelessness Process Improper packaging
Poor memory N/A - - - - N/A - -
process
Inaccurate test results due Improper inspection of
Misuse Rule-based deficits A  - to missing patient R05 Ship products that do not
information finished goods before A -  meet the specified finished R13

Knowledge-based shipment product requirements.

-
N/A - - -
deficits

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Specification
5.3 Calculating risk in a hazard situation s
The risk for each hazardous situation is estimated using available information and data. inappropriat Data elements Abnormal termination due
Abnormal
R08 inappropriate for intended to a program running out of
shutdown
2 2 4
Refer to the Risk Management Plan for severity, probability of occurrence, and risk tolerance criteria. e for use memory.

intended
The results are shown in the attached analysis table below.
use
Inadequate
disclosure Errors in product
Abnormal termination of a
Software
Assessment before R09 program due to low 3 3 9
limitations malfunction
risk control of memory or display
(severity × probability limitations
Risk A predictable sequence of occurrence) Poor
No. hazardous situation hazard
Factors of events
specifications Product failure due to Program unavailable due to Device is
Occur Risk R10 failure to perform pre-use 4 2 4
installation error unavailable
Severi rence Asse in pre-use checks
ty Likeli ssme inspection
hood nt Service and Unauthorized maintenance
Program error or disabling Device is
R01 Gravity
Product damage due to
Software Unavailability
User
1 2 2
R11 Maintenance attempts by
occurred unavailable
4 2 4
product drops inconvenience non-professionals
Specifications
Incorrect or Use of purchased goods
Improper
that do not conform to Final product does not
inappropriate Incorrect or improper
Inaccurate patient Software Abnormal
R02 output or functionality 3 3 9 R12 inspection of meet performance
shutdown
1 3 3
output or due to user malfunction
information malfunction the specified purchased requirements
purchases goods requirements
functionality Improper
Loss or
inspection of Shipment of products that
degradation Inability to store data due Data collection and storage User do not conform to Final product does not
Abnormal
R03
to insufficient capacity failures inconvenience 1 2 2 R13 finished goods meet performance
shutdown 1 3 3
of specified finished product requirements
before requirements
functionality
Lack of Deletion of information or shipment
Rework due to lost User
R04 images due to user
information inconvenience
1 2 2
attention inattention
Failure to
Inaccurate test results Misdiagnosis due to
User
R05 follow the due to missing patient inaccurate patient
inconvenience
4 2 8
information information
rule base
Incomplete
Incorrect usage Abnormal program Software
R06 usage termination malfunction
3 3 9
instructions
instructions
Incomplete
description
Abnormal termination due
Missing description of Abnormal
R07 of functional device characteristics
to a program running out of
shutdown 2 2 4
memory.
characteristi
cs

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5. Risk Assessment 1) A higher value calculated for a risk indicates a higher risk level.

5.1 Severity criteria 2) All identified risks should be reduced to the lowest possible level with appropriate control
measures implemented.
Severity Level Description
- Risk control measures should be implemented to reduce the risk to the extent that it can be

Critical Permanent damage or life-threatening injury

reduced.
4
- If other risks are encountered in the process of implementing risk control measures, the risk
Injury or damage that requires professional acceptability assessment for that risk must be performed again.
Serious 3
medical attention risk tolerance assessment for that risk shall be conducted again.
Temporary injury or damage that does not - Perform a risk/benefit analysis and record information related to the risk/benefit determination,
Minor 2
require professional medical attention. even if risk control measures are implemented.

Negligible 1 Discomfort or temporary unpleasantness

6. Risk Control
5.2 Likelihood criteria 6.1 Risk control (reduction) measures for a total of 18 hazards identified in the risk assessment
conducted for this product were applied sequentially for the following three items.
Occurrence Levels Description Possible situations
a) Inherent safety by design (design)
Occasional 4 30 ≤ X < 200 User inconvenience b) Preventive measures in the medical device itself or in the manufacturing process
(manufacturing)
Remote 3 10 ≤ X < 30 Software malfunctions c) Information on stability (information provision)

Abnormal Shutdowns Risk Risk Control Verification

Improbable 2 2 ≤ X < 10 No. Risk Risk Controls Rationale
/Information loss Factors Methods Results
Intrinsic safety by design
Incredible 1 0 ≤ X < 2 Unavailable devices - -
(design)
Precautions in the medical
User device itself or in the
5.3 Risk assessment results based on risk tolerance Inspecting Final Examination
R01 Gravity inconven
Report
Acceptable
ience manufacturing process packaging
Occasional (manufacturing)
Stability information
- -
(informational)
Pos Remote 2 3 Intrinsic safety by design
sibil - -
(design)
ity Precautions in the medical
Improbable 3 2 3
Incorrect or device itself or in the
- -
inappropriat Software manufacturing process
Incredible R02 malfunct Acceptable
e output or ion (manufacturing)
functionality Clarify how to use
Negligible 1 Marginal 2 Critical 3 Major 4 Stability information and what to look
Total = 16 User Manual
(informational) out for in the
Severity user manual

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Intrinsic safety by design Intrinsic safety by design

- - - -
(design) Incomplet (design)
Loss or Precautions in the medical e Precautions in the medical
device itself or in the device itself or in the
degradati - - descriptio Abnorma - -
User manufacturing process manufacturing process
l
R03 on of inconven Acceptable R07 n of shutdow
Acceptable
ience (manufacturing) n
(manufacturing)
functional functional
Clarify how to use Clarify how to use
ity Stability information and what to look character Stability information and what to look
User Manual User Manual
(informational) out for in the istics (informational) out for in the
user manual user manual
Intrinsic safety by design Intrinsic safety by design
- - - -
(design) (design)
Specificat
Precautions in the medical Precautions in the medical
device itself or in the Inspecting
ions device itself or in the
Final Examination Abnorma - -
Lack of User manufacturing process packaging Report inappropr l manufacturing process
R04 inconven Acceptable R08 shutdow
Acceptable
attention ience (manufacturing) iate for n
(manufacturing)
Clarify how to use intended Clarify how to use
Stability information and what to look Stability information and what to look
User Manual use User Manual
(informational) out for in the (informational) out for in the
user manual user manual
Intrinsic safety by design Intrinsic safety by design
- - - -
(design) (design)
Inadequa
Precautions in the medical Precautions in the medical
Failure device itself or in the te device itself or in the Manufactured to
Inspecting the
- - a Standard of
to follow User manufacturing process disclosur Software manufacturing process Work
Bill of Materials
R05 inconven Acceptable R09 malfunct Acceptable
the rule ience (manufacturing) e of ion (manufacturing)
base Clarify how to use limitation Clarify how to use
Stability information and what to look Stability information and what to look
User Manual s User Manual
(informational) out for in the (informational) out for in the
user manual user manual
Intrinsic safety by design Intrinsic safety by design
- - - -
(design) (design)
Precautions in the medical Poor Precautions in the medical
Incomplet device itself or in the device itself or in the Manufactured to
specification Device Inspecting the
- - a Standard of
e usage Software manufacturing process is manufacturing process Work
Bill of Materials
R06 malfunct Acceptable R10 s in unavaila Acceptable
instructio ion (manufacturing) ble
(manufacturing)
pre-use
ns Clarify how to use Clarify how to use
Stability information and what to look inspection Stability information and what to look
User Manual User Manual
(informational) out for in the (informational) out for in the
user manual user manual

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Intrinsic safety by design Loss or

- -
(design) R03 degradation of 1 1 1 OK Benefit Acceptable
Service and
Precautions in the medical
Maintenanc Device functionality
is device itself or in the
R11 e - - Acceptable
unavaila manufacturing process R04 Lack of attention 1 1 1 OK Benefit Acceptable
Specificatio ble
(manufacturing)
ns Stability information User Manual, Failure to follow
User Manual R05 4 1 4 OK Benefit Acceptable
(informational) Training
the rule base
Intrinsic safety by design
- -
(design) Incomplete usage
Inspect purchases R06 3 1 3 OK Benefit Acceptable
Improper Precautions in the medical according to the instructions
Abnorma raw material Inspecting a Incomplete
inspection l device itself or in the
R12 inspection Purchase Acceptable
of shutdow manufacturing process standards in the Receiving Report description of
n R07 2 1 2 OK Benefit Acceptable
(manufacturing) product standard functional
purchases
upon receipt.
Stability information characteristics
- - Specifications
(informational)
Intrinsic safety by design R08 inappropriate for 2 1 2 OK Benefit Acceptable
Improper - -
(design) intended use
inspection Precautions in the medical Inadequate
Abnorma Inspect according
of finished device itself or in the Inspecting a Final
l to finished goods R09 disclosure of 4 1 4 OK Benefit Acceptable
R13 Examination Acceptable
goods shutdow manufacturing process inspection
n Report limitations
standards
before (manufacturing)
Stability information Poor specifications in
shipment - - R10 4 1 4 OK Benefit Acceptable
(informational) pre-use inspection
6.2 Assessing residual risk after risk control measures
Service and
For more information on risk/benefit analysis and residual risk acceptability assessment, see "8. for more
R11 Maintenance 3 1 3 OK Benefit Acceptable
information.
Specifications
Improper inspection
R12 1 2 2 OK Benefit Acceptable
of purchases
Pre-control risk
assessment Improper inspection
(severity × probability of R13 of finished goods 1 2 2 OK Benefit Acceptable
Assess overall
occurrence) Completion of Risk/benefit before shipment
No. Risk Factors residual risk
Control analysis
acceptability
Occurr
Risk
ence 6.3 Completion of residual risk controls
Severity Assess
Possibil
ment 6.3.1 Assurance of complete control of all identified hazardous situations
ity
Control measures have been implemented for the identified hazards and the level of risk has
R01 Gravity 1 1 1 OK Benefit Acceptable
been reduced as shown below. The table below provides assurance that all risks have been
Incorrect or controlled and assessed.
R02 inappropriate output 3 1 3 OK Benefit Acceptable
or functionality [Before risk control measures]

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7. Evaluation of Total Residual Risk Tolerance

Occasional 7.1 It can be concluded that the level of residual risk of the product has been reduced after applying the risk control
measures for the identified hazards..
Pos Remote 2 3
sibil
7.2 Risk and benefit analysis
ity
Improbable 3 2 3
Risk Predictable sequence
No. Hazardous Situation Hazard Risk and benefit analysis
Factors of events
Incredible
Identified and managed in
product packaging,
Negligible 1 Marginal 2 Critical 3 Major 4
manufacturing processes, and
Total = 16 User
Product damage due to finished product inspection
Severity R01 Gravity product drops
Software unavailable inconvenien
ce reports Risk is unlikely to
occur.
The benefits of using it far
outweigh the risks
[After risk control measures]
It is not easy to reduce the
comprehensibility because it is
Occasional a part that may be shaken by
Incorrect or
the user's proficiency, but it is
inappropriate Incorrect or improper
Incorrect information Software judged that by explaining the
Pos Remote R02 output or functionality
about the patient malfunction use method in detail in the
sibil output or due to user malfunction
user manual, the risk factor
ity functionality will be reduced and the
Improbable 4
benefit from using the
product will be greater.
Incredible 3 3 3 It is judged that the user's
inconvenience would have
Loss or
been reduced and the harm
Negligible 1 Marginal 2 Critical 3 Major 4
degradation Inability to store data due Data collection and
User to the patient would have
Total = 16 R03
to insufficient capacity storage failures
inconvenien
of ce been reduced by specifying
Severity
the method of use and
functionality precautions for use in the
user manual.
Lack of Deletion of information or
Rework due to
User Although the user manual
R04 images due to user inconvenien specifies how to use the
information loss
attention inattention ce
product and precautions when
using it, it is difficult to
reduce the probability of
occurrence if the user ignores
Failure to it. However, since it is a
Inaccurate test results Misdiagnosis due to User
R05 follow the due to missing patient inaccurate patient inconvenien product used in hospitals, it is
information information ce judged that by explaining how
rule base to use it in detail, the risk
factor will be lowered and the
benefits of using the product
will be greater.

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It is not easy to reduce the Use of purchased goods The benefits of being able to
comprehensibility because it is Improper The final product see and manage raw material
that do not conform to does not meet Abnormal
a part that may be shaken by R12 inspection of performance shutdown
inventory, manufacturing
the user's proficiency, but it is
the specified purchased processes, and finished
Incomplete purchases goods requirements requirements
Incorrect usage Abnormal program Software judged that by explaining the product storage are significant.
R06 usage termination malfunction use method in detail in the
instructions Improper
instructions user manual, the risk factor The benefits of being able to
inspection of Shipment of products that The final product see and manage raw material
will be reduced and the do not conform to does not meet Abnormal
benefit from using the R13 finished goods performance shutdown inventory, manufacturing
specified finished product processes, and finished
product will be greater. before requirements
requirements product storage are significant.
Incomplete We believe that providing shipment
users with a user manual that
description Abnormal termination specifies how to use the
Missing description of due to an Abnormal
R07 of functional device characteristics out-of-memory shutdown product and precautions for ※ The risks identified have been reduced to an acceptable level and it can be concluded that the
program. use will reduce the risk of
characteristi benefits of treatment with this product outweigh the residual risks. It is considered necessary to
harm and increase the
cs benefits of using the product. perform an additional risk analysis based on information obtained after production.
Specification We believe that providing
s users with a user manual that
Abnormal termination specifies how to use the
inappropriat Data elements
due to an Abnormal
R08 inappropriate for intended
out-of-memory shutdown
product and precautions for
e for use
program. use will reduce the risk of
intended harm and increase the
benefits of using the product.
use
We believe that providing
Inadequate users with a user manual that
Abnormal termination specifies how to use the
disclosure Errors in product due to an Software
malfunction product and precautions for
R09
limitations out-of-memory
of program. use will reduce the risk of
limitations harm and increase the
benefits of using the product.
Poor The benefits of being able to
specifications Product failure due to Program unavailable see and manage raw material
Device is
R10 failure to perform pre-use due to installation
unavailable inventory, manufacturing
in pre-use checks error processes, and finished
inspection product storage are significant.
Although the user manual
specifies how to use the
product and precautions when
using it, it is difficult to
reduce the probability of
Service and Unauthorized maintenance occurrence if the user ignores
A program error or Device is
R11 Maintenance attempts by
disabling occurs unavailable
it. However, since it is a
non-professionals product used in hospitals, it is
Specifications
judged that by explaining how
to use it in detail, the risk
factor will be lowered and the
benefits of using the product
will be greater.

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7.3 Assess the acceptability of the overall residual risk 9. Production and Post-Production
The acceptability of the residual risk was assessed through the risk and benefit analysis, but in
the end, the assessment of the overall residual risk was reassessed for acceptability through the 9.1. From the time the product is placed on the market, production and post-production information
following items. shall be continuously managed in accordance with the safety information reporting regulations and risk
1) Review the user manual (User Guide) management plan, including adverse events, which are part of the quality management system (such as
2) Review by experts
GMP).
Include everything you can to help people avoid the This refers to the process of investigating and collecting safety information and adverse events that
Review the user manual risks they are exposed to, including warnings and
occur during the life cycle of a device, including storage, transportation, handling, use, and disposal,
proper usage.
and the occurrence of harm, in order to prevent the harm from spreading further and to take prompt
Review by experts Review by the Managing Director action to prevent the same harm from recurring.
By collecting information on the development of medical and scientific technologies, we monitor them
Therefore, the total residual risk was reviewed secondarily against the above items, and it was
at all times so that we can apply measures to eliminate harmful factors that could not be solved by
determined that the benefits of using the product by minimizing the frequency of the risk
outweighed the residual risk, and it was finally decided to allow all of them. previous technologies to our devices, and by collecting the harmful situations of other companies'
similar products, we take measures to identify, eliminate, and plasticize the same harmful factors that
7.4 Residual risk disclosure may exist in our devices.
Through the risk management activities of our endoscopic image detection and diagnostic aid Hazardous factors identified through the above production and post-production information collection
software, many risks have been eliminated and addressed. However, risks may occur at any time
shall be implemented in a step-by-step procedure in accordance with the risk management plan, and
due to lack of management and lack of user attention. We believe that if we strive to minimize
the results of hazard control measures, verification, and evaluation based on production and
and improve the residual risks that may occur through continuous quality system management
and maintenance and continuous monitoring, the benefits of use will be much greater than the post-production information shall be recorded and managed as this risk management report.
risks.
Post-production information is managed to ensure that the various relevant sources of information
8. Risk Management Report are clearly described and that the required review of the information collected is detailed and
Prior to the sale, you must review the risk management file created by us to ensure that the risk
specific. Where the review of information indicates safety implications, actions related to the
management process is adequate.
specific medical device and risk management process are identified and linked to design and
Review Related Rationale Review Approval development. The results of the assessment should be used as input for the review of the
Is the risk management plan adequate Risk Management adequacy of the risk management process by top management, and from this perspective, the risk
performed? Plan
management process is now managed to be more closely linked to the management review
Risk Management
process.
Is the overall residual risk acceptable? Reports
See section 8
Are adequate methods in place to obtain Risk Management 9.2 Information collection
relevant production and post-production Reports 9.2.1 Manufacturing sales quantity : Ask production and sales for a year's worth of manufacturing
information ? See section 10
sales quantities.
Sales quantities are specifically broken down by model,

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domestic, and international. management review meeting to identify the status and request corrective measures.
9.2.2 Number of customer complaints : Ask your sales team for the number and nature of
customer complaints over the course of a year. 9.5 Record
Break down complaints by category, country, etc. All records of risk management shall be kept and maintained in accordance with the Quality
9.2.3 Development Changes : Request development changes, reasons, and actions from the Record Management Procedure.
development department for one year.
9.2.4 Market conditions for similar products : Research the U.S. FDA's one-year history of
incidents/recalls, the European Health Agency's
history of incidents, and the Korean Ministry of
Food and Drug Safety's history of incidents.
9.2.5 Related articles and literature : Check to see if any new papers or literature have been
published in the past year.
We then investigate and manage their relevance to our
products.
9.2.6 New specifications : Research new standards relevant to your product to see if they apply.
9.2.7 Others : Use as information in the event of an investigation that even remotely involves our
products.

9.3 Information review

9.3.1 The collected information is itemized by the risk manager to create a risk management
monitoring report.
9.3.2 In the risk management monitoring report, the information collection process (period, person
in charge, etc.), details of itemized information, and related departments shall be specified,
and risk management meetings and review requests shall be conducted.
9.3.3 Participants in the meeting or the person who received the monitoring request will write and
communicate the results of the review.

9.4 Actions
9.4.1 Product-related monitoring content is forwarded to the development department for review
and corrective action.
Ensure that the development review documentation identifies the procedures to be changed
or applied, and that they are reviewed, verified, and validated.
9.4.2 Monitoring related to quality system management shall be placed on the agenda of the

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10. FMEA Report

Evaluation
of Total
Risk Analysis Risk Assessment Risk Control Residual
Risk
Tolerance
Risk Control
Pre-Assessment
Hazard Possi Possi
Identifi Hazard Hazardous bility Risk controls Execution bility Residual
Hazard Risk Control Methods
cation Factors situations Sever of (Minimal measures) Rationale Sever of risk
Risk Risk
No. ity occur ity occur
renc renc
e e
Inherent safety by design
- -
(design)
Precautions in the medical
device itself or in the Final Acceptab
Software User
R01 Gravity unavailable inconvenience
1 2 2 Inspecting packaging Examination 1 1 1
le
manufacturing process Report
(manufacturing)
Stability information
- -
(informational)
Incorrect Inherent safety by design
- -
(design)
or
Precautions in the medical
inappropri Incorrect device itself or in the
information Software - - Acceptab
R02 ate about the malfunction
3 3 9 manufacturing process 3 1 3
le
output or patient (manufacturing)

functional Stability information Include instructions

User Guide
ity (informational) and cautions in the

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user guide.
Inherent safety by design
- -
(design)
Loss or
Precautions in the medical
degradati device itself or in the
Data collection Acceptab
User - -
R03 on of and storage
inconvenience
1 2 2 manufacturing process 1 1 1
le
failures
functional (manufacturing)
Include instructions
ity Stability information
and cautions in the User Guide
(informational)
user guide.

Inherent safety by design

- -
(design)

Precautions in the medical

Lack of Rework due to User device itself or in the Acceptab
R04 1 2 2 Manufacture to a Inspecting the 1 1 1
information loss inconvenience le
attention manufacturing process Standard of Work Bill of Materials
(manufacturing)
Include instructions
Stability information
and cautions in the User Guide
(informational)
user guide.

Inherent safety by design

- -
(design)

Failure to Misdiagnosis Precautions in the medical

due to Acceptab
User device itself or in the
R05 follow the inaccurate
inconvenience
4 2 8 - - 4 1 4
le
patient manufacturing process
rule base information (manufacturing)
Stability information Include instructions
User Guide
(informational) and cautions in the

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user guide.
Inherent safety by design
- -
(design)
Incomplet Precautions in the medical
device itself or in the
e usage Abnormal
Software - - Acceptab
R06 program 3 3 9 manufacturing process 3 1 3
malfunction le
instructio termination
(manufacturing)
ns Include instructions
Stability information
and cautions in the User Guide
(informational)
user guide.
Inherent safety by design
Incomplet - -
(design)
e
Precautions in the medical
descriptio Abnormal
program device itself or in the
Abnormal - - Acceptab
R07 n of termination due
shutdown
2 2 4 manufacturing process 2 1 2
le
to low memory
functional (manufacturing)
or display errors
characteri Include instructions
Stability information
and cautions in the User Guide
stics (informational)
user guide.
Inherent safety by design
Specificati - -
(design)
ons Precautions in the medical
Abnormal
device itself or in the
inappropri program
Abnormal - - Acceptab
R08 termination due 2 2 4 manufacturing process 2 1 2
shutdown le
ate for to low memory
(manufacturing)
or display errors
intended Include instructions
Stability information
and cautions in the User Guide
use (informational)
user guide.
R09 Inadequat Abnormal Software 3 3 9 Inherent safety by design - - 4 1 4 Acceptab

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(design)
e Precautions in the medical
disclosure program device itself or in the Manufacture to a Inspecting the
termination due Standard of Work Bill of Materials
of to low memory malfunction manufacturing process le
or display (manufacturing)
limitation errors
Include instructions
Stability information
s and cautions in the User Guide
(informational)
user guide.
Inherent safety by design
- -
(design)
Poor
Precautions in the medical
specificati Program device itself or in the Manufacture to a Inspecting the
unavailable due Device is Acceptab
R10 ons in to installation unavailable
4 2 4 manufacturing process Standard of Work Bill of Materials 4 1 4
le
pre-use error (manufacturing)
Include instructions
inspection Stability information
and cautions in the User Guide
(informational)
user guide.
Inherent safety by design
- -
Service (design)
and Precautions in the medical
Maintena A program device itself or in the Acceptab
Device is
R11 error or 4 2 4 - - 3 1 3
nce unavailable manufacturing process le
disabling occurs
Specificati (manufacturing)

ons Stability information

User Manual, Training User Guide
(informational)
The final
Improper product does Abnormal Inherent safety by design Acceptab
R12 1 3 3 - - 1 2 2
not meet shutdown (design) le
inspection performance

EI-RMP-001 A4(210×297mm)
 Doc No EI-RMR-02
Risk Management report
Rev Date 2023.06.30

Rev No 0
ENAD
Page 41/41

Precautions in the medical Inspect purchases

Inspecting a
device itself or in the according to product
Purchase
standard raw material
of manufacturing process Receiving
inspection criteria
requirements Report
(manufacturing) upon receipt
purchases
Stability information
- -
(informational)
Improper Inherent safety by design
- -
inspection (design)

The final Precautions in the medical

of Inspecting a
product does device itself or in the Inspect according to
Abnormal Final Acceptab
R13 finished not meet
shutdown
1 3 3 finished goods
Examination 1 2 2
le
performance manufacturing process inspection standards
Report
goods requirements (manufacturing)
before Stability information
- -
shipment (informational)

EI-RMP-001 A4(210×297mm)