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Medical Device Contract Manufacturing Requirements and Information - Help wanted

#1
Hey,

We are an ISO 9001:2015 and ISO 13485:2016 certified medical device company. For a new Class C/D product we are planning to partner with a Contract Manufacturer who will be develop, manufacture and test the product. I have heard about Contract Manufacturing but have failed to find a guidance document specific to medical devices.

Few more pointers:

1. The contract manufacturer does not have ISO 13485. What will be the repercussions of it?
2. Where can I understand more about quality agreement and the ownership of tasks?
3. How will the QMS of our company will come into play since they are doing most of the job?
4. Can I see a few samples of the quality agreement so I can understand more on it? Are the controls set up in this agreement? How to define the controls?
5. Guidance / Regulatory requirements if any?
6. Any other things that you want to add on.

The whole contract manufacturing and it's requirements are confusing to me. I will be glad if we can have a discussion around it so that I can learn and understand better.
 

Philip B

Involved In Discussions
#3
Your Notified Body will probably view the contract manufacturer as a critical sub-contractor. If they don't have 13485 your NB may well audit them at your cost, possibly fail them then re-audit, again at your cost. However, why are you considering using a contract manufacturer who doesn't have 13485? It is pretty much an entry level requirement in the medical device world. I think you should consider finding yourself a 13485 registered partner and save yourselves a sea of trouble. Even then you will need to audit them, have a technical agreement in place, set up measures and monitors, control of specifications etc etc.
 
#4
Your Notified Body will probably view the contract manufacturer as a critical sub-contractor. If they don't have 13485 your NB may well audit them at your cost, possibly fail them then re-audit, again at your cost. However, why are you considering using a contract manufacturer who doesn't have 13485? It is pretty much an entry level requirement in the medical device world. I think you should consider finding yourself a 13485 registered partner and save yourselves a sea of trouble. Even then you will need to audit them, have a technical agreement in place, set up measures and monitors, control of specifications etc etc.
Thank you Philip for your reply. The reason why we are going with a critical manufacturer without a ISO certification is because 'they' have the expertise to build the product and we are kind of depending on them if we are to take up this project. They have a couple of proto units ready and are testing them on their own for a while. The product will be Class B (at least!). So, its like they know the 'know how' and we will be taking them as our critical manufacturer. But since we will be the legal manufacturers, we want to be sure of everything.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
1. The contract manufacturer does not have ISO 13485. What will be the repercussions of it?
@Philip B has given you a good in-a-nutshell answer. You'll have to be very diligent in making sure that the CM does everything it has to do so that YOU still comply with all your QMS (13485) and applicable regulatory requirements. That in turn will probably call for some (not necessarily small) changes in the CM's work practices, and these will most likely not be completely smooth if they're not used to working in the medical field, and take some time. And the latter, in turn, may call for some difficult negotiations before an agreement can be signed. Make sure you and them know upfront what's involved and make sure to include all that in the contract.
2. Where can I understand more about quality agreement and the ownership of tasks?
You can purchase the ISO 13485 Handbook - it covers quality agreements fairly well. There have also been some discussions on this topic here - use the search function (top right).
3. How will the QMS of our company will come into play since they are doing most of the job?
Your QMS will have to include all the controls to make sure that what they provide you (the black box's output) satisfies all the requirement applicable to YOU. One way to do it in a way that I find convenient and efficient is place all those controls inside your own Purchasing Control SOP (after all, you'll be purchasing a service), possibly with an annex dedicated to CM if there are a lot of details/verbiage that would otherwise make the SOP cumbersome for all other uses (e.g. controlling other suppliers).
4. Can I see a few samples of the quality agreement so I can understand more on it? Are the controls set up in this agreement? How to define the controls?
They're usually proprietary; Yes; Refer to the guidance, or simply go through the relevant parts in 13485, or pay someone experienced to walk you through (disclosure: it's part of my line of business).
5. Guidance / Regulatory requirements if any?
As above. There's some guidance from the FDA on CM of drugs, which I don't know first hand, that might hold some useful content for you (if you go for DIY).
 

yodon

Staff member
Super Moderator
#6
Your Notified Body will probably view the contract manufacturer as a critical sub-contractor. If they don't have 13485 your NB may well audit them at your cost, possibly fail them then re-audit, again at your cost.
I may get penalized for piling on but in addition, they would likely also be the target of the unannounced audit (required at least once in the 3-yr period). And as @Philip B notes: at your cost.
 
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