A
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
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