The new MDR will affect all Medical Device manufacturers.
The availability of the text for the new European Medical Device Regulation allows manufacturers to start the process of assessing the impact it will have on their activities, and what they will need to do to be compliant with the revised requirements.
The MDR will overhaul some of the basic principles under which manufacturers have been working under the current MDD.
Implementing the MDR requires a structured approach, since the transition to new MDR CE certificates can last several years.
Join us for this free, 90 minute webinar presented by our guest Dr. Gert W. Bos, where he will be sharing with you a step-by-step practical approach to implement an EU-MDR compliance program.
How to develop a structured EU-MDR implementation plan following the 8 steps below...
*Note: Limited live seats available.
Medical Device Executives and CEOs
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
Gert has 21 years of experience in life sciences (devices and pharma), in university, industry as well as in four Notified Bodies.
His last notified body roles were Head of Regulatory and Clinical Affairs of BSI Medtech and Head of Notified Body at BSI-Germany (NB0535). He has been president of the Notified Body association TEAM-NB, and vice-chair of the Medical Notified Body forum NB-Med in Brussels.
In these roles for many years he represented notified bodies in a.o. the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRA’s, e-labeling, EUDAMED and on IVD’s, as well as the IMDRF workgroup on Regulated Product Submissions and Table of Content.
In addition, he served as NB-representative at EMA/CAT and Medical Device Collaboration group. He is a founding board member of the Dutch RAPS chapter.
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Qserve's mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements, to guide manufacturers in gaining and maintaining official market access for their safe and qualitative medical devices without making regulatory more complicated than it already is.
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