| Classes | IEC 62304:2006 Section | Document Section |
|---|---|---|
| B, C | 5.6.8 | (All) |
| A, B, C | 6.2.1.3 | 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 |
Overview
This SOP outlines the process for handling, assessing, and resolving issues related to our software products.
| Process Owner | \ |
| Key Performance Indicators | \ |
Process Steps
1. Evaluation of New Problems
New issues are logged as tickets in \
Problems may be reported by customers, users, or employees, such as customer feedback or bug reports.
Each report must include:
- The affected medical device and version
- Severity classification (outlined below)
- Detailed description of the problem, including steps to reproduce it
Problems are classified into severity levels as follows:
| Severity Classification | Description |
|---|---|
| High | Creates new or altered risks to patients that are unacceptable. |
| Medium | May result in new or altered risks to patients that are acceptable. |
| Low | All other issues. |
Any issues classified as “Medium” or higher must be reported to the person responsible for regulatory compliance (PRRC), who will then evaluate it according to the SOP Vigilance.
| Participants |
|---|
| Head of product development |
| Person responsible for regulatory compliance |
| Input | Output |
|---|---|
| New problem | Problem report logged as \ |
2. Root Cause Analysis and Procedure
The root cause of the issue is identified (when possible), and a determination is made regarding whether the problem will be fixed.
An investigation is also conducted to see if similar issues have occurred previously or if trends can be identified. If so, this is documented in the problem report.
| Participants |
|---|
| Head of software development |
| Software developer |
| Input | Output |
|---|---|
| Problem report | Updated problem report with identified cause and procedure |
3. Implementation and Verification
The bug fix is carried out. If the fix involves a modification to the product, it is managed following the SOP Change Management guidelines.
After implementation, the problem report is reviewed to ensure the fix is successful, allowing the report to be closed. Closing the problem report signifies verification of a successful resolution.
| Participants |
|---|
| Head of product development |
| Person responsible for regulatory compliance |
| Input | Output |
|---|---|
| Problem report | Problem report marked as resolved/closed |
| Implemented change |