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

[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

 

[Govind]

Vin,
We are currently working on developing Software development Plan based on ISO/IEC 12207 and IEEE 730. I have not used the Medical device sytem standard.

I thought the following link may be of some help to you:
https://home.btconnect.com/managingstandard/sdpo_1.htm
Regards,
Govind.

 

[wrodnigg]

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 (broken link removed) 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Another note: ISO 9000-3 has been replaced by ISO/IEC 90003:2004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