Certifications/Registrations to Manufacture Medical Devices

K

Ken Clope

#1
All,

We are a small EMS (Electronics Manufacturing Services) provider that is looking to enter the medical field. What certifications/registrations would be helpful? I know ISO 13845 registration is preferred (required?), but are there other certifications and/or registrations that we should be going after?

A few other items of note:

1) We are not, at this time, looking to design any products. We are simply looking to be a CM.
2) Our QMS is already registered to both ISO 9001 and AS 9100 so we already have a fairly robust platform in place and wouldn't be starting from scratch.

Thanks!
Ken
 
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M

MIREGMGR

#2
I assume that your "CM" intent will include not participating in end-user marketing and distribution?

You should be cognizant of the company-regulatory-stance categories used by US FDA, as listed at http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm. Depending on the regulatory stance and marketing actions of your customers, you might have some degree of FDA compliance responsibility and inspection exposure even though your intent is to be a CM.
 
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