And now, let's add software development - Medical Devices - Applying ISO9001:2000

A

acost

#11
New Software std

There is a new software medical devices std (sofftware life cycle) in development focussing on risk management, scm and problem resolution processes approach - but it will not be complete for a couple of years
(IEC 62304).

For now there is ISO 90003

A good website for standards information is www.12207.com
 
Elsmar Forum Sponsor
W

wrodnigg

#12
If anyone is interested in IEC 62304, I have the draft 62A/446/CD.
I will send it by mail on request.
 
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