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August 2001

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Subject:
From:
Greg Scott <[log in to unmask]>
Reply To:
TechNet E-Mail Forum.
Date:
Mon, 13 Aug 2001 12:21:53 -0700
Content-Type:
text/plain
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text/plain (58 lines)
Roger,
I use to work for  Siemens Medical  Systems and the way I remember it.
The OEM is responsible for obtaining/keeping  FDA approval for a product.
The OEM creates procedures and process to meet its and the FDAs goals.
The FDA only checks to make sure the procedures are being meet.  The
 FDA for the most part does not create procedures the OEMs.

What Siemens did, is a Printed Circuit Board fabricator and Printed Circuit Board assembler
had to meet specifics rules and goals  (GMP) set forth by Siemens.
Then Siemens audited its suppliers by what ever frequency the procedures says.
New  suppliers had to sign up to these process. Mostly quality, ESD, and travelers and
accurate
document process (ECO)  had to be handled  correctly. Thus pass audits and any given time.

In your case the OEM must provide you information of what they expect out of the suppliers.
Hope this helped.  Mostly our printed circuit board fabricators were not effected as long as
they
kept accurate records and good documentation process.

Greg Scott
designer
Cray Inc.

Roger Hammond wrote:

> Dear Techneters,
>                 I work for a Printed Circuit Fabricator in the U.K.and one of our
> customers, a Printed Circuit Assembler has been approached by an OEM
> that produces medical equipment. This OEM has FDA approval for his
> product. The question is, is it the equipment that is FDA approved or
> does it transfer down the line to the assembler and printed circuit
> manufacturer in similar fashion to UL recognition. If it transfers down
> the line how does one go about obtaining the approval.
>
> Thank you  in advance
>
> Roger Hammond
>
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