Risk Management SOP ISO 14971

ZSal2309

Registered
Hi everyone

I am about to write a risk management SOP based on ISO 14971 and I need inspiration. What do you, based on experience, recommend that the procedure should include? The procedure will be performed on a prototype and should not be comprehensive.
If you can provide me with templates or documents sure I will be happy :)
 

yodon

Leader
Super Moderator
ISO 14971 and the companion 24971 should provide sufficient inspiration for what the procedure should include: everything from planning to postmarket analysis.

I don't understand:
The procedure will be performed on a prototype and should not be comprehensive.

What do you feel can be excluded from complying with 14971? Why?

If the intent is to get to market (via the prototype) then you would want to follow 14971 in full. If you do an attachment search, I'm sure you'll find some good materials. But remember: risk management is not just an FMEA.
 
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