European Union Device Regulation (EU MDR)

Edwin Waldbusser
Instructor:
Edwin Waldbusser
Date:
Thursday, December 16, 2021
Time:
10:00 AM PST | 01:00 PM EST
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 504196

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
Combo Offers
Live + Recorded
$289 $340 Live + Recorded
Corporate (Live + Recorded)
$599 $680 Corporate
(Live + Recorded)
Price Detail Options
Overview:

The EU MDR replaces the MDD and expands the requirements for conformance. The MDR contains 174 pages with 123 "Articles" in 10 "Chapters" and 17 "Annexes".

In contrast the MDD has 60 pages. New requirements are added and existing requirements are expanded. The MDR is effective May 2020 leaving limited time to prepare.

These new and expanded requirements will be explained. Attendees should have a reasonable understanding of FDA regulations.

Why you should Attend: The EU MDR will be effective in May 2020. Products intended to be imported into the EU must conform to these new regulations. Arrangements must be made with a Notified Body, an Authorized Representative and a Person Responsible for Regulatory Compliance.

There is extensive preparation necessary. This webinar will explain what needs to be done to meet the deadline.

Areas Covered in the Session:

  • EU MDR objectives
  • QMS requirements
  • Device classification changes
  • Documentation requirements
  • Clinical evaluation requirements
  • UDI and labelling requirements
  • Post market surveillance
  • New Notified Body obligations
  • Human Factors/ Usability requirements

Who Will Benefit:
  • Engineers
  • Regulatory personnel
  • Quality Assurance personnel
  • Marketing
  • Management
  • Importers of medical devices
  • Distributors of medical devices


Speaker Profile
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.


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