Q
quest
In 1997, during a CE audit, we were cited for not indentifying the MDD as 'one of the requirements that the company intended to comply with.' MDD Annex 5, 3.2 was referenced. As a result we added to our policy that we "operate in accordance with the Quality System Regulation as required by the U.S. Food and Drug Administration and the Medical Device Directive (93/42/EEC) of the European Economic Community."
We are reviewing (and shortening) our Quality Policy and the question came up whether this specific reference to FDA and MDD was required. Our QMS conforms to ISO13485 as well as cGMP.
I would appreciate your opinion on this. Can we remove the specific references or was the 1997 auditor correct?
We are reviewing (and shortening) our Quality Policy and the question came up whether this specific reference to FDA and MDD was required. Our QMS conforms to ISO13485 as well as cGMP.
I would appreciate your opinion on this. Can we remove the specific references or was the 1997 auditor correct?