SOP Software Problem Resolution
IEC 62304:2006
Classes Section Document Section
B, C 5.6.8 (All)
A, B, C [Link] 1
A, B, C 6.2.2 (All)
A, B, C 9.1 1
A, B, C 9.2 2
A, B, C 9.3 3
A, B, C 9.5 1
A, B, C 9.6 2
A, B, C 9.7 3
Summary
This SOP describes how problems concerning our software product(s) are processed,
evaluated and fixed.
Process Owner <enter role of process owner>
Key Performance Indicators <enter KPIs to be tracked for the Management Review>
Process Steps
1. New Problem Evaluation
New problems are entered as tickets into <your ticketing system>.
Reported problems can originate from customers, users or company employees. Examples
include customer feedback and bug reports.
For each problem report, the following must be entered:
• Affected medical device and version
• Severity classification (see below)
• Problem description incl. instructions to reproduce
We classify the severity of problems in the following categories:
Severity Classification Description
High Causes new or changed risks to patients which are
unacceptable.
Medium May cause new or changed risks to patients which are
acceptable.
Severity Classification Description
Low All other problems.
For all problems classified as “Medium” or higher the person responsible for regulatory
compliance (PRRC) must be informed who subsequently assesses it according to the SOP
Vigilance.
Participants
Head of product development
Person responsible for regulatory compliance
Input Output
New problem Problem report as <ticket in your ticketing system>
2. Root Cause Analysis and Procedure
The root cause of the problem is determined (if possible) and a decision is made whether to
fix it or not.
We also analyze whether similar problems have occurred in the past and any trends can be
discerned. If this is the case, it is noted in the problem report.
Participants
Head of software development
Software developer
Input Output
Problem report Problem report updated with cause
and procedure
3. Implementation and Verification
The bug fix is implemented. If the fix includes a change to an existing product, it is handled
according to SOP Change Management.
After the bug fix has been implemented, the problem report is reviewed whether it has
been successfully fixed and can be closed. Closing the problem report is equivalent to
successful verification.
Participants
Head of product development
Person responsible for regulatory compliance
Input Output
Problem report Resolved/closed problem report
Implemented change
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