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Articles written by Hamish Forster

The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up

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 »

Basic Anatomy of a Design Dossier

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 »