EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations

Instructor: Robert J Russell
Product ID: 705801
  • Duration: 90 Min
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2018

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU. The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU.

This workshop will be of great value to Medical Device professionals and those involved or interested in the registration of Medical Devices across the EU.

Areas Covered in the Webinar:

  • EU Regulatory and Legislative Structure
  • EU Definition of a Medical Device
  • 3 EU Directives -> 2 EU Regulations
  • Key Agencies Involved
  • Why the change from Directives to Regulations?
  • Overview of CE Marking Process & Changes Resulting from the EU MDR
  • Updated Role of the Notified Body
  • Medical Device Classifications
  • Essential Requirements Safety & Performance Requirements
  • Integration of Risk Assessment / Risk Management
  • Conformity assessment
  • Device Vigilance & Reporting System
  • MDR Overview (by Article & Annex)
  • ISO 13485:2016 Updates
  • Medical Device Single Audit Program (MDSAP)
  • Global Impact of ISO 13485:2016 Certification and CE Marking
  • Tips on Working with Regulatory Authorities

Who Will Benefit:

This workshop will be of great value to Medical Device professionals and those involved or interested in the registration of Medical Devices across the EU. It is primarily designed to benefit personnel within the following disciplines:

  • Executive Management
  • Quality Assurance
  • Regulatory Affairs
  • Clinical research and medical operations
  • Product Development
  • Manufacturing / Distribution
  • Medical Device R&D
  • Clinical trial supply
  • CROs
Instructor Profile:
Robert J Russell

Robert J Russell
President, RJR Consulting, Inc

For the past 9 years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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