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

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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!

Workshops - "The NEW CE MARKING"

- IVDR implementation
August 9, 2019 - Anaheim, CA, USA


Meet us!

AACC
August 4-8, 2019
Anaheim, CA, USA
Booth #1709

RAPS
September 21-24, 2019
Phiadelphia
Booth #200






Contact MDSS

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
contact us





MDSS Management & Personnel

Ludger Möller
President


Responsibilities:

  • President of MDSS
  • Safety Officer


Education/Experiences:

  • Over 17 years experience in all aspects of European Regulation (CE Marking)
  • Since 2000 President of MDSS
  • Since 2003 Member of the European Commission´s Medical Device Expert Group
  • 1996-2000 Lead Auditor and Expert with leading Notified Body (TUV)
  • 1997-2000 Office Manager of the San Diego TUV office
  • 1995-1996 Research and Development of Medical Devices
  • University degree (Dipl. Engineer), Aachen University of Technology


Member of:

  • European Commission´s Medical Devices Expert Group
  • Regulatory Affairs Professional Society (RAPS)

 



Joy Grimm

Senior Consultant



Responsibilities:

  • Regualtory Affairs Consulting for IVD
  • Main contact for IVD (In-Vitro Diagnostic)


Education/Experiences:

  • Medical Laboratory Technologist
  • Quality Management - Continuing Education (Quality Management Representative)
  • Since 2008 Consultant IVD Medical Devices - CE
  • 2007-2011 Regulatory Specialist - CE
  • 2000-2002 Office Manager
  • 1981-2000 Clinical Laboratory - RIA Dept. Supervisor (Germany)
  • 1977-1980 Medical Technologist - Serology (USA)


Member of:

  • Regulatory Affairs Professional Society (RAPS)



Tom Barkow, Dipl.-Ing. (FH)
Senior Consultant



Responsibilities:

  • Regulatory Affairs Consulting
  • Quality Management Consulting
  • Safety Officer
  • Reimbursement for Medical Devices (Medical Technical Aids Registration-HMV)
  • Central Pharmaceutical Number (PZN) Application


Education/Experiences:

  • University of Applied Science Ostfriesland/Oldenburg/Wilhelmshaven, Diploma in "Medical Technology"
  • Quality Management - Continuing Education (Quality Management Representative & Auditor)
  • 2009-2010 Quality Management Representative
  • Since 2009 Consultant RA/QA and Safety Officer
  • Internship: Aesculap AG & Co. KG division: "R&D Hip Aethroplasty"


Member of:
  • Regulatory Affairs Professional Society (RAPS)

Elsa Villanueva-Moeller
Director of Administration / Business Development



Education/Experiences:

  • Diplom degree (DePaul University, Chicago)
  • Previously worked as Director of Marketing in several Fortune 500 companies
  • Owned and operated an internet Company



Guido Rainis, state-certified food chemist
Consultant



Responsibilities:

  • Regulatory Affairs Consulting for Cosmetics
  • Main contact for Cosmetics


Education/Experiences:

  • 2009 – 2013 Research in Analytical Chemistry on the Institute of Food Toxicology and Analytical Chemistry of the University of Veterinary Medicine Hannover
  • 2009 State examination Food Chemistry (Lower Saxony State Office for Consumer Protection and Food Safety, LAVES)
  • 2008 University degree (Diploma) Food Chemistry (Technical University of Braunschweig)