Update on IEC 62304 revision - May 2012 - 2013 (TBD)

Yes Tidge, I agree!

Sooooo, per 62304, for any standard libraries that get compiled into code I have to figure out which ones are, and then document:
a) the title,
b) the MANUFACTURER, and
c) the unique SOUP designator

How am I sure I have this done right? What does 'correct' look like? Contrived situation, let's say I'm writing in C using the MSP430G2101 with CCS.

Med_Eng said:

How am I sure I have this done right? What does 'correct' look like? Contrived situation, let's say I'm writing in C using the MSP430G2101 with CCS.

Click to expand...

You ought to be able to rebuild and release identical software as was subject to the initial deployment. To support the (on market) lifecycle of the deployed solution you need enough information to re-evaluate and rework the initial deployment.