Risk Management 820.30g & ISO 13485 § 7.1, 7.3.3, & 7.3.9 (Executive Series #21)

[@paulstorrie2888]

Could you do a video on how to actually assess the risks on user requirements, and functional requirements? There's a lot of info on what we need to do but very little demonstrations on how it is actually done, Thanks

[@QualitySystemsExplained]

Hi Paul, Great feedback! Right now I am in the middle of a big series of videos on pharma cGMPS. I cannot promise I will create something good and I will put some thought into the “How to” question. Maybe I can develop something simple that I can present in under 3 minutes. 😊 Thank you for commenting. Sincerely, Aaron

[@TeW33zy]

Is design controls risk management? Does it say u must meet ISO 14971 or what?

[@QualitySystemsExplained]

Hi Docudrama, Design Controls and Risk Management are two separate processes that work together to produce a safe and effective medical device. Risk Management is used to define, document, and implement the Design Controls processes. Risk Management is also used throughout the QMS. ISO 13485 does point to 14971 in sections 7.1. It is also identifed for multiple definitions in section 3. I hope that helps. :) Sincerely, Aaron

[@TeW33zy]

@@QualitySystemsExplained ok. I just don't see any section in 21 CFR 820 series that outlines Risk Management like ISO: 13485:2016 as it points to 14971. 21 CFR doesn't point to any risk management procedure that requires a DFMEA, PFMEA etc like 14971 does.