"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!"
Jim Luker RN, MS, RAC
Sun Nuclear Corp.
"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."
Parker Laboratories, Inc.
“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.”
"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."
Manager of Quality Assurance & Regulatory Affairs
Epitope Diagnostics, Inc.
“The MDSS workshop as very informative and gave me a deeper understanding of IVDR.
What I thought was most helpful were the specific examples in industry (whether hypothetical or from actual experience) that were presented along with the requirements in the regulation.
This workshop provided a lot of tips and suggestions that I will be revisiting as we begin the transition into this regulation.”
Quality Assurance Manager
"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."
"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."
Senior Specialist, Regulatory Affairs
"The workshop was extremely informative and presented in an easy to understand manner, especially for something as dense as the MDR."
"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!"
“MDSS is the one stop resource for all your Medical Device Regulation needs.”
EEZCARE Medical Corp.
"It was a very interesting workshop and a pleasure to meet Mr. Moller."
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."
Kat DeBarris, R.A.C.
"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."
Regulatory Affairs Manager
"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."
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”.
Piet H Lesage