Medical device other market

adztesla

adztesla

Starting to get Involved
Hi all,

I have just joined as a sustaining engineer for a startup company. As part of my job, I am asked to transfer a couple of products to production with product codes of other markets. In order to do that, regulatory have suggested using DCAF (design change assessment form) and DR (Design review checklist) to implement them in production. This is because we have no other documents to review the requirements for transfer to production.

Do anybody who has previous experience on the above suggest?


Thanks,
Smitha
 
E

EmiliaBedelia

Involved In Discussions
Without knowing anything about the product or the additional target markets and without looking at the documents you are referencing, it's hard to say whether they are sufficient or not. Presumably your regulatory/quality team has more experience in your particular company's procedures and documents than anyone here, so personally I think they are probably your best resource.

At minimum you should document the requirements for the desired international markets, the evidence that shows the product design meets those requirements, and that your manufacturing process is capable of producing product that meets those requirements. You should also ensure that all the required design control documents are complete for these particular product codes. Most importantly, you need to ensure that you are following your own company's internal procedures - regardless of whether you think something is necessary or not, you have to follow your own QMS (and if you think something should be done differently, make sure everyone is on board with a justification as to why).
 
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