When CE marking medical software, you must create and compile a technical file, where you need to include, as follows:
- Risk management documentation
- Usability documentation
- Software - development documentation
- Clinical evaluation
- And, you should also include any other documents related to the EU medical device approval process that you may have.
Usually, each part of the technical file of your product can consist of more than one document. For example, the software-development documentation part could contain information about:
- The software-development plan
- The software requirements and architecture
- The code and code reviews
- The static code analysis
- The unit, integration and system tests
- Software validation and release.
Get help with the CE marking approval for medical device by contacting our team at firstname.lastname@example.org.