IVD Device History Record

[SamSx]

Hi all,

I was wondering as part of ISO13485 and 21 CFR 820, what documents would you expect to see in a DHR and what checks would be required on these records prior to QA approval?
Thanks
S

 

[yodon]

At a high level, Design Planning, Risk Management, Design Inputs, Design Outputs, Design Verification, Design Validation, Design Reviews, etc. (pretty much as laid out). If there's software, then there's another set of software-specific docs.

Not sure what you mean by "checks" - all docs are reviewed, approved, and released. Up to you to define more specifics on those activities (and generally is not just QA approval).

Can you be more specific?

 

[SamSx]

Hi,

thank you for your reply.

I wasn’t sure what documents to expect in a DHR. Also as a quality auditor, I’d be required to review these documents and my question is, what types of things would I be expected to audit in these documents. What sort of things will I audit to ensure compliance in these documents?
I hope that makes sense

thanks
S

 

[yodon]

That subject is probably too broad for a discussion board. You need to review the regulations and understand relevant guidance docs / standards to really drill down on content requirements. For example, if your product has software then you will have software requirements (as part of the design inputs). IEC 62304 lists out types of requirements that would be expected. The software requirements also need to trace to system requirements (another design input). 62304 also has a software risk aspect (if class B or C) and those may also drive software requirements. ISO 14971 (risk management) and IEC 62366 (Usability Engineering) would potentially drive other software requirements and the linkage between the source of the software requirements and the origination should be maintained. So as you can see, things get rather complicated rather quickly.

 

[Watermelonsg]

Hi Yodon,

I have a question with regard to one section in DHR which is the acceptance records.

Currently, corresponding to pFMEA failure modes, we have acceptance criteria for all these failures. From right length measured by a jig to a connector color checked by visual inspection, the number adds up to 400 for all steps.

To my knowledge, in ISO 14971, it states the risk should be reduced as low as reasonably practical based on severity and occurrence. It does not say anything if there should be some sort of detection like acceptance check as part of DHR.

I am puzzled as what is the guideline to refer to decide if all or some of the failure modes should be translated into acceptance check in DHR?

I meant some with S=2, O=2, should it be inside DHR? what is the general guideline?

 

[yodon]

For PFMEAs, I still use detection.