In Reply to Parent Post by guzzi
I am new to the cove and it is a great resource. I am working in QA at a start-up software development company that is conforming to 13485:2003, but is questionable that it is a medical device in the classic sense.
Software itself can be as a medical device depending on its purpose.
I just have links to european documents, but they may be helpful:
MEDDEV 2. 1/1
MEDDEV 2. 1/ 2.1
MEDDEV 2.4/1 Rev.8
There are several guidelines to software validation, especially this one
you might be interesting for you.
There is also a new revision of the AAMI standard SW68
Another note: ISO 9000-3 has been replaced by ISO/IEC 90003:2004