A: IEC 62304 is very program oriented, so be ready to show your procedures during your onsite MDR or IVDR audit. In the technical file submission, consider the following: the summary information into your dossier, which would include interoperability, security controls, reference to design and items such as that. Also consider writing a formal 62304 report. You also may submit your test plans, your maintenance plans, and your validation reports and your software requirements specifications as required by your notified body.
Procedures are not typically included in a technical file submission. These will be needed for the first part of your conformity assessment, and your onsite MDR or IVDR audit.
The requirements of IEC 62304 should be blended into your other quality procedures, which includes but is not limited to, software design and development, risk management, change control, control of nonconformities, CAPA, post-market surveillance and vigilance reporting.
IEC 62304 is program oriented, so be ready to show your procedures during your onsite audit.
Note: It’s recommended to cite your reference standards and regulations at the end of your procedures.
A: Just remember that there are more requirements for safety classes B and C than they are for A. Below is a list; note that all procedures are also required by ISO 1345/MDR/IVDR.
Procedures listed here:
- Software requirements specification
- Software development plan
- Software maintenance plan
- Software test plan
- Change control procedure
- Control of nonconformities procedure
- CAPA procedure
- Post-market surveillance procedure
- Vigilance reporting procedure
- Gap analysis and documentation of follow-up activities
- Legacy software planning