MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE

Get a Quote from MDSS Your Authorized Representative forMedical Devices and In Vitro Diagnostic Devices

News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • Have MDSS, your Authorized Representative, apply for a Free Sales Certificate/Certificate of Marketability on your behalf! more


  • Cosmetic Products in Europe
    Latest News


    
HIGHLIGHTS
Keep up to date!

News and Views June 2017

News and Views May 2017 - Latest Update


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




EVENTS
Meet us!

Cosmoprof North America
July 09-11, 2017
Las Vegas, USA
Booth: #33140

AACC
August 01-03, 2017
San Diego, USA
Booth: #1941


Join us!

MDSS Workshop (IVDR)
August 04, 2017
San Diego, USA
Read more...


MDSS Workshops (MDR)

August 07 - 11, 2017
USA




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)

 




Hans Haindl
Chairman, MDSS Scientific Advisory Board



Education/Experiences:

  • University degrees, both in medicine and mechanical engineering
  • 6 years clinical experience, mainly anesthesiology and surgery
  • More than 25 years in R&D and in the investigation of medical devices
  • 4 years as department head, R&D, B.Braun AG
  • Since 1991 Independent consultant, (R&D/clinical evaluations, regulatory affairs), to medical device manufacturers
  • Since 1989 Officially appointed by the German Chamber of Commerce, to act as a publicly certified expert for medical devices
  • 1994 - 2007 Chairman of the German Federation of Medical Device Experts (BSM)
  • Since 1996 Member of the Ethical Committee for Lower Saxony
  • Since 1996 Expert for the Federal High Court of Germany (patent nullity)
  • 1990 - 1995 Lecturer for medical technology at the University of Applied Sciences in Wilhelmshaven
  • 2003 - 2005 Lecturer for medical technology at the University of Applied Sciences in Bremerhaven
  • Many publications, presentations, patents and licenses



Frank Wilmerstaedt, Dipl.-Ing.
Director Consulting



Responsibilities:

  • Lead of the Consultant Group
  • Consultant RA/QA


Education/Experiences:
  • 2012-2014 Director Q&RA at a medical device manufacturer
  • 2011-2012 Q&RA Consultant Medical Devices
  • 2006-2011 Director Certification at Notified Body
  • 1998-2011 Lead Auditor and Expert at Notified Body
  • 1995-1998 Technical Product Manager
  • 1991-1995 University of Applied Science, Hamburg - Biomedical engineering
  • 1988-1991 Qualified Electronics Engineer at Aircrafts
  • 1985-1988 Education in Electronics


Member of:

  • RAPS 


Jens Gerdelmann, Dr. rer. nat., Dipl.-Biol.
Senior Consultant



Responsibilities:

  • Regulatory Affairs Consulting
  • Quality Management Consulting
  • Safety Officer


Education/Experiences:

  • German university degree in biology (Diploma)
  • Research doctorate in natural science (Dr. rer. nat)
  • Quality Management - Continuing Education (Quality Management Representative & Auditor)
  • 2011-2012 Quality Management Representative
  • Since 2009 Consultant RA/QA and Safety Officer
  • 2008-2009 Research in biophysics, molecular and cell biology at the medical faculty of the University of Göttingen, Germany
  • 2002-2008 Research in biophysics, neurosciences, molecular and cell biology at the medical and physics faculties of the University of Leipzig, Germany
  • 2002 Internship at the Physics Department of the University of Texas in Austin, USA


Member of:
  • Regulatory Affairs Professional Society (RAPS)



Huan Sun, PhD
Senior Manager Registration



Responsibilities:

  • National Registration (Germany)
  • Consultant Regulatory Affairs
  • Quality Management Consultant
  • Acquisition Chinese customer


Education/Experience:

  • Since 2012 Registration, Consultant RA/QA, acquisation Chinese customer
  • German university degree in Biomedical Engineering (M.Sc.)
  • Research doctorate in engineering (Phd)
  • 2008-2012: Research in Cryopreservation of tissues and cells at the mechanical engineering faculty of the Leibniz Universität Hannover and Hannover medical school "Cluster of Excellence Rebirth", Germany.
  • 2006-2008: Studies in Biomedical Engineering at the mechanical engineering faculty of the Leibniz Universität Hannover, Germany
  • 2002-2006: Studies in physical engineering at the university of applied sciences Aachen, Campus Jülich, Germany
  • Language skills: Chinese



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)



Annika Matz, Dr. rer. nat., Dipl.-Biol.
Senior Consultant



Responsibilities:

  • Regulatory Affairs Consulting
  • Quality Management Consulting
  • Safety Officer


Education/Experience:

  • German university degree in biology (Diploma)
  • Research doctorate in natural science (Dr. rer. nat)
  • Quality Management - Continuing Education (Quality Management Representative & Auditor)
  • Since 2015 Consultant RA/QA and Safety Officer at MDSS Consulting GmbH
  • 2014 Employee at IVD manufacturer
  • 2012-2014 Postdoctoral Research in neuroscience at MPI for exp. Medicine in Göttingen, Germany
  • 2008-2012 Doctoral training at the Göttingen Graduate School for Neurosciences and Molecular Biosciences (GGNB)/ Max Planck Institute for Experimental Medicine



Gesine Köhne, Dr. rer. nat., Dipl.-Biol.
Senior Consultant



Responsibilities:

  • Regulatory Affairs Consulting
  • Quality Management Representative


Education/Experiences:

  • German university degree in biology (Diploma)
  • Research doctorate in natural science (Dr. rer. nat)
  • Since 2012 Quality Management Representative at MDSS
  • Since 2011 Consultant RA/QA at MDSS
  • 2001-2008 Research in stem cell biology at the Medical School Hannover, Germany
  • 1995-2001 Studies in biology, Leibniz University Hannover, Germany
  • 1998-1999 Studies abroad at the North Eastern University Boston, MA, USA



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)