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For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certification?

P

pschnoor9

#1
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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CarolX

Super Moderator
Super Moderator
#2
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.
 
M

MIREGMGR

#3
Re: For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certificat

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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