Working with Notified Bodies

MDD Changes and Notified Bodies
Not all European Notified Bodies are the same. In light of the recent proposed updates on the Medical Devices Directive, in this e-conference we present the information you need to select the best fit Notified Body and how to work with it.

Learning Objective
Learn how to select the right Notified Body out of the 80+ available organizations, and how to successfully cooperate with it.

We will discuss:
[x] The European Regulatory System for Medical Devices
[x] How the most recent proposed updates on the Medical Devices Directive will affect your relationship with Notified Bodies.
[x] How to identify the criteria for selecting the right Notified Body.
[x] Pros and cons of selecting a US or EU based Notified Body.
[x] The importance of defining the intended use for the product; which in turn controls the classification and available conformity assessment procedure.
[x] How to establish an overall plan for the cooperation between the manufacturer and the Notified Body.

You will receive
[x] An expert speaker in Mr. Poul Schmidt-Andersen
[x] New information about working with Notified Bodies
[x] PowerPoint slides
[x] A chance for Q&A
[x] 0.15 CEUs and Certificate of Attendance

Audience Suitability
[x] Medical device manufacturers
[x] Sponsors of clinical trials
[x] Regulatory professionals
[x] Marketing professionals
[x] Staff involved in European clinical trials
[x] Executives who are planning their company’s future

Presenter:
Clinical Device Group is proud to present Mr. Poul Schmidt-Andersen, B.Sc. EE, B.Comm. After many years in the medical devices business, in 1994 Poul started the Danish Medical Devices Certification Organization (DGM), a Notified Body for the IVDD and MDD Directives. While at DGM he acted as Vice-Chairman for the Notified Bodies Medical Devices Group, which is designed to promote co-operation between Notified Bodies, medical device manufacturers and the EU-Commission. As Managing Director of DGM he was responsible for its development until July 2001, when he resigned to start his own consulting firm, Copenhagen Medical Devices Consulting. He can be reached at psa@cmd-consulting.com. 

The purchase is $421 for OnDemand access and $471 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.