Software Development Plan - Startup Software Development Company - 13485:2003

G

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.

Does anyone have or can point to what a software development plan should look like. Not a template, but an actual SDP. We have one, but trying to get a sanity check.

Vin :thanx:
 
W

wrodnigg

guzzi said:
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.

Hello guzzi,

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 "under construction" ;)

Another note: ISO 9000-3 has been replaced by ISO/IEC 90003:2004

HTH-HAND
 
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