Process Development Requirements for a Contract Manufacturer with no Design

R

rdesmond

#1
Hello!

We are a contract manufacturer with no design responsibility. We, however have a group that develops processes & works collaboratively with our customers who are both the Spec developers & Medical Device mfgs. The question - if we want to include this group under our 13485 registration, what would be required? Is it simply to ensure that our Quality Planning process adequately covers what they do or do we have to comply with the full-blown 7.3 D & D section? Thanks!!
 
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K

kgott

#2
Hello!

We are a contract manufacturer with no design responsibility. We, however have a group that develops processes & works collaboratively with our customers who are both the Spec developers & Medical Device mfgs. The question - if we want to include this group under our 13485 registration, what would be required? Is it simply to ensure that our Quality Planning process adequately covers what they do or do we have to comply with the full-blown 7.3 D & D section? Thanks!!

Because no one else has had a go at this I'll do my best. IMO it would be wise to apply the requirements of 7.3 because you need to plan and design how you are going to do that which you are going to do for the customer. You might only do it once but you are still planning and designing the service.

Hopefully those more knowledgeable than me in this area will help you out.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hello!

We are a contract manufacturer with no design responsibility. We, however have a group that develops processes & works collaboratively with our customers who are both the Spec developers & Medical Device mfgs. The question - if we want to include this group under our 13485 registration, what would be required? Is it simply to ensure that our Quality Planning process adequately covers what they do or do we have to comply with the full-blown 7.3 D & D section? Thanks!!
Hi,

Saying "no design responsibility" and "develops processes" is a contradiction.

Design is not limited to part geometry etc. It also includes the manufacturing process(es).

Cheers,
Ronen.
 
R

rdesmond

#4
We have had no problem excluding D & D. As I re-read section 7.3 - it talks about "development of product...inputs to product requirements." We do none of this. Our customer is wholly responsible for drawings & specs. We are, yes, developing the manufacturing processes to meet these requirements. Products go through a complete validation before customer commercialization. I still go back to - do we HAVE TO comply w/ 7.3 or can we keep this as part of Quality Planning? We are not usually party to customer design information until they release drawings. Thanks again!
 
J

JulieChisholm

#5
Just make sure those responsibilities are defined in your quality agreement. It sounds like you are merely conducting the studies or performing tasks dictated by your client, who holds the design responsibility, i.e. you are performing the verification and validation work.
 
M

MIREGMGR

#6
ISO 13485 doesn't go to who's responsible for resulting medical devices under the MDD. It addresses what activities you do in order to make and deliver whatever is your product, whether that's a service, a subassembly or a contract manufactured device. The standard doesn't apply only to finished device makers. It doesn't matter who's ultimately responsible for realization activities...only whether you do some of them.

I agree with Ronen E and KGott. You do such activities, therefore they must be included in your scope.
 
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