Working Effectively with Notified Bodies

Why should you take this eConference?
You should take this eConference because not all Notified Bodies are the same.
Objective:
• Learn to select the right Notified Body out of the 60+ available organizations.
• Learn to successfully cooperate with a Notified Body.
Description:
As the former Vice Chairman for the European Notified Bodies, Poul Schmidt-Andersen brings a unique perspective to their expectations. In this presentation he will discuss what companies do badly and offer assistance in doing it well.
You will learn:
• About the European Regulatory System for Medical Devices and the most resent proposed updates on the Medical Device Directive and how they affect your relationship with Notified Bodies.
• The importance of defining the intended use for the product; which, in turn, controls the classification and available conformity assessment procedure.
• How to identify the criteria for selecting the right Notified Body.
• How to establish an overall plan for the cooperation between the manufacturer and the Notified Body
• How to organize documentation for compliance of medical devices to be submitted to the Notified Body
• How to document quality system, plan and carrying out Notified Body audits of the systems.
You will get:
• Recording of the presentation
• The Medical Devices Directive (EU Commission)
• The IVD Medical Devices Directive (EU Commission)
• Summary Technical Documentation for demonstrating Conformity to the Essential Principles of safety and performance of medical devices (GHTF)
• Guideline for regulatory Auditing of Quality Systems of Medical Devices Manufactures (GHTF)
• MEDDEV on classification of medical devices (EU Commission)
• MEDDEV on vigilance reporting (EU Commission)
• ..and more
Who Should Attend:
This eConference is designed for the staff of medical device manufacturers with regulatory responsibility and marketing people who want to know the regulatory requirements of marketing products in Europe.
Presenter:
In 1994 Mr. Poul Schmidt-Andersen started 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 when he resigned to start his own consultancy firm, Copenhagen Medical Devices Consulting aps. Until leaving DGM he acted as Vice-Chairman for the "Notified Bodies Medical Devices Group" which was designed to promote co-operation between Notified Bodies, medical device manufacturers and the EU-Commission. Read more about Poul Schmidt-Andersen or contact him at psa@cmd-consulting.com

The purchase is $400 for the CD. Event materials are available on the CD itself. 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.