Hi,

My understanding is that the DOC has to be signed by an officer of the
company that has the responsibility and authority (stop shipment if not in
compliance) of the product.  In your case the Compliance Engineer may have
the responsibility but probably not the authority.  The President would have
both the responsibility and authority and unless there was fraud involved,
he is going to be liable.

Ned Devine
Entela, Inc.
Program Manager III
Phone 616 248 9671
Fax  616 574 9752
e-mail  [email protected] 

-----Original Message-----
From: Mark Schmidt [mailto:[email protected]]
Sent: Wednesday, December 20, 2000 1:55 PM
To: Courtland Thomas; emcpost
Subject: RE: Responsibilities



Courtland,

It has always been my understanding that the Company/President or VP of
Engineering is ultimately responsible for product compliance. Ignorance of
Regulatory law  at a senior management level is not a valid excuse. Granted
the Compliance person may be terminated in the process, but the
responsibility resides with the Company.

Mark Schmidt

 -----Original Message-----
From:   Courtland Thomas [mailto:[email protected]] 
Sent:   Wednesday, December 20, 2000 4:06 PM
To:     emcpost
Subject:        Responsibilities


Hello group,

I have a question concerning responsibility when signing off on compliance
issues.

Who is ultimately responsible for the product, the compliance engineer or
the company. Let's say that a device has been 'Self Declared' to be 'CE'
compliant. The D of C is signed by the compliance engineer as well as the
President of the company. For some reason, whatever it may be, the unit is
found to be non-compliant. Who gets locked up? I may be exaggerating
somewhat, but you get the idea.

Courtland Thomas


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