| Classes | IEC 62304:2006 Section | Document Section |
|---|---|---|
| A, B, C | 5.8.1 | (All) |
| A, B, C | 5.8.2 | (All) |
| A, B, C | 5.8.3 | (All) |
| A, B, C | 5.8.4 | (All) |
| B, C | 5.8.5 | (All) |
| B, C | 5.8.6 | (All) |
| A, B, C | 5.8.7 | (All) |
Overview
This checklist is designed to ensure that all necessary documentation and tasks are completed before a software release.
As with any regulatory documentation, the focus is on the substance, not the format. You don’t need to complete this checklist in Word, Google Docs, or similar; it can be integrated into tools like Jira or GitHub workflows. The primary goal is that all listed items should be checked and documented before releasing a new software version.
You can add additional rows to this checklist as needed to match your company’s requirements. This template represents the essential elements for IEC 62304 compliance.
Checklist
Ensure the following documents are current:
The table below provides examples. Make sure to include or reference all required technical documentation records.
| Item | Yes | No | Comment |
|---|---|---|---|
| Device Description | |||
| Clinical Evaluation | |||
| Declaration of Conformity | |||
| (…) |
Confirm the completion of these activities:
| Item | Yes | No | Comment |
|---|---|---|---|
| All software functionalities have been defined; the Software Requirement List is complete and reviewed. | |||
| All relevant risks, including those from known anomalies, have been assessed; the Risk Management Report is complete. | |||
| Verification, including software system testing, has been completed. | |||
| Design control traceability is maintained: Stakeholder requirements can be traced to software requirements. Software requirements are linked to system tests. Software requirements are traceable to code implementation and reviews. Software requirements are linked to risks and risk control measures. Stakeholder requirements are traceable to usability tests. Usability tests are traceable to hazard-related use scenarios. Hazard-related use scenarios are linked to risks and risk control measures. |
|||
| A version number, as specified in the Software Development Plan, has been assigned and tagged in the repository. | |||
| The software has been registered with a Notified Body. | |||
| If the release involves significant changes, the Notified Body has been notified. | |||
| Labels are correctly applied, including the CE mark. |