ISO 13485 requirements for Stand Alone Medical Device Software (Class II a)

K

Kuhalit

#1
Hello, a QM-System for a stand alone software, electronic distributed... does not really complay with the usual requirements of 13485.... A lot of things are just different, who is also struggling with the exorbitant requirements - actually, we are only design and distribution....

Thanks and regard
Andreas
 
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c.mitch

Quite Involved in Discussions
#2
Hallo Andreas
Two standards at minimum for standalone sw.
Iec 62304:
It's exorbitant if your software is of high risk (risk of death or serious impairment) in class C
Iso13485:
You have the right to exclude parts of chapter 7, with good rationale. But for the rest of the standard (all other chapters) your NB is going to be "stubborn" :)

BUT
These remenber that these standards are optional. Maybe Iso 9001 (lighter compared to iso 13485) with additional directive requirements (eg materiovigilance) and a strong technical file would be acceptable by your NB.

Tschuess
 
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