Hi,
We are developing medical device software and are looking for some more insights into how to (best) map IEC 62304 clause 9 software problem resolution with ISO 13485.
There are probably different options for implementing both standards in quality management system processes. Is there a best practice or can someone share experience on the following?
We are developing medical device software and are looking for some more insights into how to (best) map IEC 62304 clause 9 software problem resolution with ISO 13485.
There are probably different options for implementing both standards in quality management system processes. Is there a best practice or can someone share experience on the following?
- Does IEC 62304 problem resolution correspond with ISO 13485 clause 8.3 control of nonconforming product (e.g. residual anomalies - release under concession)?
- Include problems encountered after release in our more generic complaint handling process (incl. resolution) and apply a separate process for pre-release problem resolution? Or 1 problem resolution process linked to complaint handling?
- Probably similar: ISO 13485 includes requirements for complaint handling (8.2.2) & requirements for nonconforming product after delivery (8.3). Does it make sense to implement both in the complaint handling procedure or are there any reasons to separate them?