Dear Elsmar Team,
I am currently working on developing a QMS for a SaMD start-up working on AI & ML based product.
When it comes to section 8.3 Control of nonconforming product for a SaMD (Software as Medical Device), I am really confused as there wouldn't be any physical product that shall be treated as non-conforming product. At the same time, I feel we can not declare this section as 'Not Applicable'.
There might be software bugs (non-conformance) during development/after release which might be considered as complaints. For that IEC 62304 suggests 'software problem resolution'.
In that case, what could be the best solution in addressing the ISO 13485 section 8.3 Control of nonconforming product combining it with IEC 62304.
I am currently working on developing a QMS for a SaMD start-up working on AI & ML based product.
When it comes to section 8.3 Control of nonconforming product for a SaMD (Software as Medical Device), I am really confused as there wouldn't be any physical product that shall be treated as non-conforming product. At the same time, I feel we can not declare this section as 'Not Applicable'.
There might be software bugs (non-conformance) during development/after release which might be considered as complaints. For that IEC 62304 suggests 'software problem resolution'.
In that case, what could be the best solution in addressing the ISO 13485 section 8.3 Control of nonconforming product combining it with IEC 62304.
- Can we replace 8.3 Control of nonconforming product with SW problem resolution?
- What kind of SOPs are needed to address this requirement?
- Where exactly, IEC 62304 'software problem resolution' come in to picture for SaMD QMS?
- How does 8.3.4 Rework apply to SaMD products? Can we take it as 'Not Applicable'?