Tegra Medical is a rapidly growing company in the contract medical device manufacturing space. Due to our continued growth, we are expanding our sales team and are seeking a dynamic business development professional to join us.
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 »