Benefit of attending

• Awareness of the basic priciples which underpin sterilization technology
• Knowledge of the range of sterilization technologies which are available for medical devices
• Knowledge of the positive attributes and the limitation of the available sterilization methods
• Learn about the new sterilization standards
• Ability to apply the standards which have been developed for validation and routine control of sterilization of medical devices
• Understanding of the requirements for planning and conduct of an audit of a sterile medical device manufacturer

CAPA & Software Validation Tutor

Poul Schmidt-Andersen, B.Sc EE, B.Comm.

DMD Consulting aps

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.

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.