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HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION
– THE MDR/IVDR!!!

more...


In-House Workshops
"The NEW CE MARKING"
Book now
to make sure you’re ready to survive and thrive!


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Cosmetic Products in Europe

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EVENTS
Join us!

International
MDR Happening

December 11-12, 2018
Hannover, Germany



Meet us!

November 12-15, 2018
Düsseldorf, Germany
Booth #10B05




Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





Client Testimonials



"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."

Stefanie Dallezotte
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.”

Julian Hoi
Quality Assurance Manager
Genemed Operations



"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."

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."

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."

Yi Young
Principal Quality Engineer
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!"

Tina A.,
Quality Manager, Massachusetts, USA



“MDSS is the one stop resource for all your Medical Device Regulation needs.

Michelle Mitchell
EEZCARE Medical Corp



"It was a very interesting workshop and a pleasure to meet Mr. Moller."

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."

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."

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."

C2 Therapeutics