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Small Medical Device company - Bring production in-house

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#1
As the title says, we are 13485 and Class II FDA cleared and CE. We have used contract manufacturing and our ISO scope does not include manufacturing or service. We want to add production.

I have created a high-level flow chart from customer order to delivery and invoice of the connecting processes to fulfill the customer. I now want to create a knockout list of work we need to perform to meet the ISO/FDA CE requirements JUST FOR adding production. I know I can review the requirements from the standard and create a list but has anyone done something similar to this they can share in advance.

We will audit (I am 13485:2016 lead audit certified) and catch problems of course.
 
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