The Medical Device Quality Management (MDQM) program seeks to train and develop individuals who are currently employed in, or wish to enter the medical device industry or related industries.
by Hamish Forster | Aug 2012
In my previous BONEZONE article, “Basic Anatomy of a Design Dossier” (BONEZONE March 2011), I presented an overview of the key elements required within technical documentation in order to demonstrate conformity to the Medical Device Directive (MDD) 93/42/EEC. A key requirement is post-market su ... Read more »
by Hamish Forster | Mar 2011
This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity to the Medical Device Directive 93/42/EEC (MDD). It is intended to provide an overview for regulatory professionals who seek to compile technical ... Read more »