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
    
HIGHLIGHTS
Keep up to date!

THE "NEW" CE MARKING
Get your questions answered for the NEW MD REGULATION – THE MDR!!!
more...


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




EVENTS
Meet us!

MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



Join us!

9. Medical Device Networking Meeting -
a RAPS Roadshow 
November 30, 2017
Hannover, Germany

more...

10. Medical Device Networking Meeting - 
a RAPS Roadshow 
December 04, 2017
Ulm, Germany

more...



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


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)