Poul Schmidt-Andersen was head of R&D and marketing of medical devices for more than 17 years for Danish and Swedish companies. In 1994, Poul founded the DGM - the Danish Medical Devices Certification Organization, and Notified Body for the IVDD and MDD Directives.
As Managing Director of DGM he was responsible for its development until July 2001 where he resigned to start his own consultancy firm Copenhagen Medical Devices Consulting aps. In 2009 Copenhagen Medical Devices Consulting aps merged with Preventia ab. In 2010 Danish Medical Devices Consulting aps. was established.
Poul is a Lead Auditor for EN ISO 9001 / EN ISO 13485 quality systems and for the Medical Devices Directive (MDD). He is a trained FDA inspector with respect to the US requirements of the Code of Federal Regulation 21 Part 820 and as a Pre-market Notification 510(k) reviewer under the Mutual Recognition Agreement (MRA - Medical Devices Annex) between the European Commission and the US.
