Design Transfer between two companies with different QMS

Daliane

Starting to get Involved
#1
Hi everyone,

we are an engineering provider and currently taking over the entire design work of a class 1 medical product from another engineering provider. The issue we are facing is that we will receive the technical file (DHF) which is certified by the other design company. Some documents will not match our QMS, e.g. our risk management process has different evaluation and ratings. How can we adapt these documents (around 100 documents) in our QMS? Does anyone have experiences with this?

Thank you

Daliane :bigwave:
 
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shimonv

Trusted Information Resource
#2
Hi Daliane,
Unfortunately there is no easy way around this... with some of the records you can/should adopt best practices, and with the others just convert into your own QMS templates.

The only consolation that I can think of is that this is a class I device (self declaration). The notified body is not going to come after you, so you can take your time doing this. Maybe it can be a job for a new employee or student.

Shimon
 

Daliane

Starting to get Involved
#3
Lets say this is a class 2 product, could we start aligning the documents only when there is a change that impacts the documentation and else just refer on the previous transfered documentation (from the other design company) or would that be a non comformity?
 

shimonv

Trusted Information Resource
#4
That won't fly. If you are taking ownership over a class II device you need to inform your notification body and they will want to review your Technical File because your new product will bear the CE mark with their number on it.
 
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