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

[Kuhalit]

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

 

[c.mitch]

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