We have a medical device business engaged in product development only (no manufacturing, etc), and we want to earn a QMS certification. What is the best path? If ISO 13485, what exclusions? Does anyone have real-life experience with this scenario?

All replies are appreciated!

Patricia

Hi Patricia and welcome to the Cove -

Sorry you have not had a reply - I can't help you but maybe someone else can.

We have a medical device business engaged in product development only (no manufacturing, etc), and we want to earn a QMS certification. What is the best path?

If we were contracting with you for design/development services, we would want you to be ISO 13485, with due attention to FDA, Canadian, Japanese, etc., requirements as well.

Does your scope of services include regulatorily driven design-related tasks such as materials qualification documentation, risk analysis file preparation, label design, Technical File preparation, 510(k) preparation, etc.?