Part & Process Approval in Medical Devices

M

MurrayB45

#1
We used to use these being a supplier to the automotive companies. I am now in medical but we have adapted these requirements to suit, they work very well if applied correctly.
Murray
 
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K

Kira_n

#2
Re: Here are the Various AIAG PPAP Manual 4th Edition Forms

I work in Medical (but am an ex Automotive person from England supplying Ford, Rover, Toyota, Nissan etc ) and have modified the form to suit our needs. Medical has no PPAP process as such in ISO13485 but some of the large American medical companies are using the term now, so I guess it is better to be proactive and implement first before they tell you what you must do.

I am extraordinarily patient provided I get my own way in the end. - Margaret Thatcher
Hi,

What are the requirements of the large American medical companies exactly?

Regards,
Kira
 
A

achorste

#4
What type of products are you manufacturing?

It would really depend on the product type and manufacturing process as to what requirements they will demand from the supplier, but from my experience with the American orthopaedic implant OEMs (Depuy, Stryker, Zimmer and the like), only one regularly uses PPAP (or their version thereof).

Do you use any special processes in your manufacturing route?
 
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