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SOP Software Problem Resolution

Classes IEC 62304:2006 Section Document Section
B, C 5.6.8 (All)
A, B, C 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


This SOP describes how problems concerning our software product(s) are processed, evaluated and fixed.

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:

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.
Low All other problems.

For all problems classified as “Medium” or higher the person responsible for regulatory compliance must be informed who subsequently assesses it based on SOP Incident Reporting.

Under MDD, replace the Person Responsible for Regulatory Compliance with Safety Officer.

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.

Head of software development
Software developer
Input Output
Problem report Problem report updated with cause and procedure

3. Implementation and Verification

The change is implemented. If the change includes a change to an existing product, it is handled according to SOP Change Management.

After the change 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.

Head of product development
Person responsible for regulatory compliance
Input Output
Problem report Resolved/closed problem report
Implemented change

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