Questions about Table C.1 examples of hazards in Annex C of ISO 14971.

[kim sang geun]

Bye, everyone!
I am preparing for MDR.
We are developing an active medical device and working with a consulting company on risk management (ISO 14971:2019 and ISO 24971).
I'm curious about risk management.

There are Table C.1 examples of hazards in Annex C of ISO 14971.
Using the form provided by consulting, I fill out the FMEA Table from '5. risk analysis' to '8. Evaluation of overall residual risk' using the FMEA analysis technique for the hazards shown in Table C.

However, for the risks listed in IEC 60601-1, I think it is right to make an FMEA with reference to ISO 14971. This is because ISO 14971 is the standard that sets out the risk management process.

Is it necessary to conduct risk analysis of hazards as examples in ISO 14971:2019?

Thank you for your valuable reply.

 

[yodon]

Is it necessary to conduct risk analysis of hazards as examples in ISO 14971:2019?

Is it necessary? No. Is it your best path to market clearance? Absolutely!

To be honest, I would guess if you don't follow 14971, you won't ever get through the regulatory process. Risk (management) is front-and-center with the regulatory folks and they know and understand (for the most part) 14971. If you're not following that, they may not agree that you have done your due diligence on risk management.

If your consultant said "fill out this FMEA to comply with 14971" I would probably look for another consultant.