OEM/OBL Quality Agreement vs. Technical Agreement

B

BERMUDEC

#1
Good Day,

What is a difference between OEM/ OBL Quality Agreement and OEM/ OBL Technical Agreement for Medical Devices?

Thank you in advance
 
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pkost

Trusted Information Resource
#2
Re: OEM/OBL Quality Agreement vs Technical Agreement

Hi Bermudec,

where are you seeing this being written? I'm not sure there will be much of a difference between then two and if there is, I have always combined them together into one agreement.

I would imagine that the Technical agreement states at least 4 things:
1. That the NB and CA of the manufacturer can request access to the technical documentation of the OEM while maintaining confidentiality (i.e. the OEM being unaware of the technical aspects). It
2. That any changes made will result in the notification of the manufacturer so that they can inform their NB. preferably with enough notice that it won't affect production
3. Specification of any labels
4. The relationship between the manufacturer codes and OEM codes

The quality agreement will specify that:
both parties maintain a quality system (preferably 13485)
that both parties maintain a vigilance system
that both parties inform the other if there are any vigilance issues.
 
R

Robbie1

#3
Re: OEM/OBL Quality Agreement vs Technical Agreement

hi pkost
Do you have a draft of sample of an agreement that I could use as starting point please
Thanks
Rob
 
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