Risk Management and FMEAs - IEC 60812, SRC-HDBK-1120 and SEQ-J1739

[Bunny]

I work for a medical device manufacturer and have created several risk management files using ISO 14971. In my spare time I am trying to learn more about risk management, FMEAs, etc. I want to improve the process here. I was wondering if IEC 60812, SRC-HDBK-1120 and SEQ-J1739 would benefit me. Has anyone in the medical device field found these standards worthwhile?

 

[Stijloor]

I work for a medical device manufacturer and have created several risk management files using ISO 14971. In my spare time I am trying to learn more about risk management, FMEAs, etc. I want to improve the process here. I was wondering if IEC 60812, SRC-HDBK-1120 and SEQ-J1739 would benefit me. Has anyone in the medical device field found these standards worthwhile?

Comments anyone?

Thank you!!

Stijloor.

 

[sagai]

Welcome!
I think ISO14971 with IEC62366 (or IEC60601-1-6 if we like), corresponding part of IEC62304 and the GHTF RM guidance are the ones you need.
Actually ... I have never heard the ones you mentioned.
As an addition, I only would add your device dependent EU MDD only to review its content.
br
Sz.

 

[Kmortenson]

Yes, that IEC 60812 standard is very help for FMEA and FMECAs (failure modes effects and criticality analysis) because most medical device companies use that risk analysis technique inside their risk management program (per ISO 14971) as their main tool in development and post-market. You can see it listed as one of the techniques in 14971 in annex G. Occasionally I'll use FTA (fault tree analysis) if there's one or two big failures and you want a visual tool to work backwards to root cause.