Education and Training
On-Site Workshops:
"The NEW CE MARKING" MDR/IVDR implementation
Train your whole team with our tailor-made workshops - in Your Offices, with Our Team!
Throughout the year, MDSS organizes events to provide learning opportunities to our clients. Given the new medical regulations that are coming into place (MDR (EU) 2017/745 & IVDR (EU) 2017/746), it is more important than ever to provide our clients with all relevant information to enable them to cope with the new regulations.
Book now to make sure you’re ready to survive and thrive!
MDR Regulation
1 day In-House workshop
Price: $4,500
SUGGESTED TOPICS
- MDR Compliance Strategy for your Company based on product portfolio
- The new regulatory system – an overview
- Classification and Conformity Assessment (Chapter V, Annex VIII (Classification) and IX to XI (Conformity Assessment)) Application on High-Risk class product!
- Timeline for implementation, New legal aspects, Other aspects (Chapter II, X)
- Post-Market surveillance (PMS) and Vigilance (Chapter VII, Annex III)
Or customize the topics according to you company needs!
MDR/IVDR Regulation
2 days In-House workshop
Price: $7,000
SUGGESTED TOPICS
- MDR Compliance Strategy for your Company based on product portfolio
- The new regulatory system – an overview
- Classification and Conformity Assessment (Chapter V, Annex VIII (Classification) and IX to XI (Conformity Assessment)) Application on High-Risk class product!
- Notified body and Certificates issued by notified bodies, CE Marking of conformity and Declaration of Conformity (Chapter IV, Annex IV, V, VII, XII)
- Post-Market surveillance (PMS) and Vigilance (Chapter VII, Annex III)
- Member states cooperation, Medical Device Coordination Group, Experts laboratories, Experts Panels, Eudamed and UDI (Chapter III, VIII, Annex V)
- Technical Documentation, Clinical Evaluation, Clinical Investigation Post-Market Clinical follow up (PMCF) (Chapter VI, Annex I, XIV, XV)
- Timeline for implementation, New legal aspects, Other aspects (Chapter II, X)
Or customize the topics according to you company needs!
"The MDSS New CE Marking Workshop provided invaluable information on all aspects of the EU MDR, from transition timing to implementation details, including ongoing discussions the CA’s and NB’s are having for aspects of the MDR that are still being worked out. I highly recommend this workshop for anyone who will be involved in preparing their company to implement the new MDR regulations."
Invaluable information on all aspects of the EU MDR
Candy Beck, Regulatory Specialist, Parker Laboratories, Inc.
"We had the pleasure of attending MDSS's two day 'New CE Marking Workshop'. It was nothing short of Amazing! Given the anxiety that naturally accompanies being ready for the onslaught of the MDR, I have attended many training offererings which purported 'actionable' guidance on implementing the MDR. MDSS's on-sight workshop presented by Ludger Moller, was the first to actually deliver on the promise! Ludger presented a great deal of information which was directly relevant and which we will use in our MDR preparation plan. Ludger presented the information in a clear and concise manner with humor and relevant real-life examples. If you are planning on attending an MDR worshop, this is the one to choose. You will not regret your decision!"
We had the pleasure of attending MDSS’s two day ‘New CE Marking Workshop’.
Jim Luker RN, MS, RAC, Regulatory Consultant, Sun Nuclear Corp.
"MDSS’s New CE Marking Workshop was informative and thoughtfully planned, with an effective mixed format of presented material and meaningful discussion. All presenters were knowledgeable, engaging and readily able to answer questions. Overall, it was an excellent orientation to the MDR and a great value."
An effective mixed format of presented material and meaningful discussion
Sarah Carey, Conformis, Inc.
"By the end of the workshop lead by MDSS, I was aware of the key changes introduced by the new regulations, which has supported our transition plans."
The key changes introduced by the new regulations
Stefanie Dallezotte, Manager of Quality Assurance & Regulatory Affairs, Epitope Diagnostics, Inc.
"Be prepared and start now is the strong message from our trusted EU Authorized Representative, MDSS. Geared up and ready, MDSS’ The “New CE” Mark workshop provides keen insight for overcoming impending regulatory challenges now."
Be prepared and start now
Gloria Zuclich, Collagen Matrix
"This workshop was very helpful in gaining further insight into the New CE Marking/ MDR / IVDR requirements/implementation. I liked the speed of the presentation, topics covered, and materials provided, as well as the accommodations. Ludger Möller's English/presentation was pleasant & surprisingly easy to understand. Thanks for this training & I look forward to future training w/MDSS."
This workshop was very helpful in gaining further insight into the New CE Marking/ MDR / IVDR requirements/implementation.
Kim Bloom, Senior Specialist, Regulatory Affairs Accriva Diagnostics
"The workshop was extremely informative and presented in an easy to understand manner, especially for something as dense as the MDR."
Presented in an easy to understand manner
Yi Young, RxSight Inc.
"This one-day seminar was tremendously valuable in providing us an orientation for the new MDR. The presenters were knowledgeable, articulate, helpful and, with this foundation, we can now start planning the implementation of these new regulations. Thank you MDSS for organizing this event!"
An orientation for the new MDR
Tina A., Quality Manager
"MDSS is the one stop resource for all your Medical Device Regulation needs."
MDSS is the one stop resource
Michelle Mitchell, EEZCARE Medical Corp.
"It was a very interesting workshop and a pleasure to meet Mr. Moller."
A very interesting workshop
Paul Vagts, Director of Regulatory Affairs, Parcus Medical LLC
"The New CE Marking Roadshow is engaging, informative and a great value. The material was well organized and the presenter kept it fun and interesting. You really can’t get this level of training for this price anywhere else."
The presenter kept it fun
Kat DeBarris, R.A.C. RA/QA Analyst, Encision Inc.
"MDSS is a superb partner in supporting Gammex as Authorized Representative. I really enjoyed attending MDSS' “The New CE Marking” Workshop in Chicago. Ludger Moeller’s presentation was engaging and informative and I will look for opportunities to attend MDSS seminars."
MDSS is a superb partner
Jeff Shaw, Regulatory Affairs Manager, Gammex Inc.
"MDSS has served as our European Authorized Representative since 2016. MDSS staff have been extremely helpful in providing guidance and assistance in the areas of vigilance reporting, Field Safety Corrective Actions, and general communications with Competent Authorities in Europe. The staff are knowledgeable, experienced and always provided prompt responses to our inquiries."
MDSS staff have been extremely helpful
C2 Therapeutics
"Ludger Möller and MDDS bring a perspective on MDR that’s different from the NB perspective. For that reason alone, even if they are already familiar with MDR, Regulatory Affairs professionals can benefit from taking part in the “New CE Marking Workshop."
MDDS brings a perspective on MDR that’s different from the NB perspective
Piet H Lesage, Principal Consultant, GB5D, LLC