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Old 6th April 2009, 03:53 PM
pschnoor9 pschnoor9 is offline
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Question For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certification?
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
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Old 20th April 2009, 12:36 PM
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Default Re: For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certificat
Hi Patricia and welcome to the Cove -

Sorry you have not had a reply - I can't help you but maybe someone else can.
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Old 20th April 2009, 01:27 PM
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Default Re: For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certificat
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Originally Posted by pschnoor9 View Post

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.?
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