An Introduction to the New EU Medical Device Regulation

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar


May-16-2017 at 01:00 PM EST | 12:00 PM CST | 10:00 AM PST

At the completion of this webinar, participants will be able to discuss the changes to the MDR as compared to the current Medical Device Directives in terms of notified bodies, clinical evidence, pre-market, transparency and traceability, and governance and oversight.  Also to be discussed, will be the strategy that will be employed to transition to the new MDR to ease the burden upon compliance.  There will also be a general navigation review of the regulation with a discussion of the contents of each relevant section.

Why should you attend -

Sometime this year, the EU, we expect, will vote on the official texts of the new Medical Device Regulation and the new InVitro Diagnostic Regulation.  The current MDR stands at 350 pages and is a complex array of regulations written in the normal legalese.  There are many changes that anyone designing, manufacturing, and/or marketing medical devices into the EU needs to be aware of when compared to the original Medical Device Directives.  This webinar will detail the changes and discuss their implications upon medical device manufacturers. 

Areas Covered

•   Current state of the MDDs and MDR
•   Transition period
•   Key changes – notified bodies, clinical evidence, pre-market, transparency and traceability, governance and oversight
•   Regulation overview
•   Changes to rules
•   Conformity assessment procedures
•   Notified body designation
•   How this new regulation will impact US companies

Who will Benefit

•   Audit and Compliance Personnel / Risk Managers
•   Research and Development Engineers
•   Vice-Presidents, Directors, and Managers of medical device design functions
•   Medical device marketing personnel

Industries who can attend

This online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

Speaker Profile

Charles H Paul

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues. 

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military. 

He has dedicated his entire professional career explaining the benefits of performance-based training

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