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ABOUT MDSS
About MDSS
MDSS Team
Authorized Representative

MDSS
serves clients' specific needs with changes
of products and regulations.  Each client is unique and MDSS customizes the solution for each client individually.

 

 
MDSS Team

 

Ludger Möller

Managing Director, Safety Officer
  • 12 years experience in all aspects of European Regulation (CE marking) concerning Medical Devices.
  • Since 2000 President of MDSS.
  • Since 2002 Deputy Chair of the European Association of Authorized Representatives (EAAR).
  • Since 2003 Member of the European Commission’s Medical Device Expert Group.
  • 1996-2000 Lead Auditor and Expert with leading Notified Body (TUV) for quality system review and product safety testing
  • 1997-2000 Office Manager of the San Diego TUV office.
  • 1995-1996 Research and Development of Medical Devices.
  • University degree (Diploma) in mechanical engineering (Aachen University of Technology, major in biomedical engineering)
  • Member of RAPS and member of the European RAPS committee 

Hans Haindl, MD

Chairman, MDSS Scientific Advisory Board
  • University degrees, both in medicine and mechanical engineering.
  • 6 years clinical experience, mainly anaesthesiology and surgery.
  • 20 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.
  • Since 1994 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.
  • Since 2003 Lecturer for medical technology at the University of Applied Sciences in Bremerhaven.
  • Many publications, presentations, patents and licenses

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Juergen Mehring

RA/QA Manager, Safety Officer
  • Since 2008: Project manager RA QA, safety officer
  • 4 years experience in all aspects of European Regulation (CE marking) concerning Medical Device
  • 2004-2007: approval procedures medical devices; Quality- and Risk-Management, safety officer;
  • 2000 – 2003: Research and Development Medical Devices
  • 1999: Applied University degree (Diploma) in applied physics (major in biomedical engineering)

 

 


Joy Grimm

IVD Manager, Safety Officer
Management Representative
  • 8 years regulatory specialist in product registration and vigilance evaluation
  • 20 years clinical experience with IVD devices in management position
  • Medical Laboratory Technologist
  • Work experience in Germany and the USA
  • Native English speaker
  • RAPS Member

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Peter Plantiko, MD

Safety Officer 
  • Head of Department for Anesthesiology and Critical Care, Buchholz County Hospital 
  • 8 years experience in R & D and assessment of Medical Devices

 

 


Julia Warnemann

International Management Assistant
  • Contact for
    • MDD Vigilance Reporting
      National Registration, France
  • Higher European Diploma in Marketing and International Trade (HEDMIT)
  • Economic Assistant emphasizing Foreign Languages and Correspondence
  • Trilingual
  • Professional Experience abroad

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Bianca Rieger

RA/QA Assistant

  • Contact for
    • Product Registrations
    • Cosmetics and Biocidal Products
    • German Medical Technical Aids Register (Hilfsmittelverzeichnis)
    • National Registration, Spain and Italy
  • Bachelor of Arts in International Communication and Translation
    Trilingual
  • Professional Experience Abroad

 

 


Ulrike Zeglin

Administrative Assistant
  • Office Administration and Correspondence
  • Invoicing
  • Management Assistant for Office Communication

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