The MDSS Consultancy Management and Personnel Team
Ludger Möller
President/Safety Officer
Responsibilities:
President of MDSS
Education/Experiences:
Member of:
Hans Haindl
Chairman, MDSS Scientific Advisory Board
Joy Grimm
Senior Consultant
Responsibilities:
Education/Experiences:
Member of:
Jens Gerdelmann, Dr. rer. nat., Dipl.-Biol.
Senior Consultant
Responsibilities:
Education/Experiences:
Tom Barkow, Dipl.-Ing. (FH)
Senior Consultant
Responsibilities:
Education/Experiences:
Gesine Köhne, Dr. rer. nat., Dipl.-Biol.
Consultant
Responsibilities:
Julia Warnemann
Senior Manager Registration
Responsibilities:
Education/Experiences:
Katrin Oppenheimer
Manager Registration
Responsibilities:
Education/Experiences:
Martina Meysing
Manager Registration
Responsibilities:
Education/Experiences:
Petra Bodonge
Manager Registration
Responsibilities:
Education/Experiences:
Ulrike Zeglin
Consultant Vigilance
Responsibilities:
Education/Experiences:
Sophie - Canan Kurt
International Management Assistant
Responsibilities:
Education/Experiences:
Karolina Tarapata
Administrative Assistant
Responsibilities:
Education/Experiences:
President/Safety Officer
Responsibilities:
President of MDSS
Education/Experiences:
- 15 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 (Diploma), Aachen University of Technology
Member of:
- European Commission´s Medical Devices Expert Group
- RAPS
Hans Haindl
Chairman, MDSS Scientific Advisory Board
- 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
Joy Grimm
Senior Consultant
Responsibilities:
- Consultant RA 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)
- Language skills: English and German
Member of:
- RAPS
Jens Gerdelmann, Dr. rer. nat., Dipl.-Biol.
Senior Consultant
Responsibilities:
- Consultant RA/QA
- Safety Officer
- Quality Management Representative
Education/Experiences:
- German university degree in biology (Diploma)
- Research doctorate in natural science (Dr. rer. nat)
- Quality Management - Continuing Education (Quality Management Representative & Auditor)
- Since 2011 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
- Language skills: German and English
Tom Barkow, Dipl.-Ing. (FH)
Senior Consultant
Responsibilities:
- Consultant RA/QA
- Safety Officer
Education/Experiences:
- University of Applied Science Ostfriesland/Oldenburg/Wilhelmshaven, German degree (Diploma) in "Medical Technology"
- Quality Management - Continuing Education (Quality Management Representative & Auditor)
- 2009-2011 Quality Management Representative
- Since 2009 Consultant RA/QA and Safety Officer
- Internship: Aesculap AG & Co. KG divison: "R&D Hip Aethroplasty"
- Language skills: German and English
Gesine Köhne, Dr. rer. nat., Dipl.-Biol.
Consultant
Responsibilities:
- Main contact for Authorized Representative clients
- Vigilance Reporting
- Regulatory Affairs
- German university degree in biology (Diploma)
- Research doctorate in natural science (Dr. rer. nat.)
- Since 2011 Consultant Authorized Representative
- 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 aborad at the North Eastern University Boston, MA, USA
- Language skills: German and English
Julia Warnemann
Senior Manager Registration
Responsibilities:
- National Medical Device Registration
- Reimbursement for Medical Devices (Medical Technical Aids Registration-HMV)
- Central Pharmaceutical Number (PZN) Application
- MDD, IVDD and AIMDD Vigilance reporting
Education/Experiences:
- Higher European Diploma in Marketing and International Trade (HEDMIT)
- Economic Assistant emphasizing Foreign Languages and Correspondence
- Language skills: German, English, French and Spanish
- Work experience in Belgium
Katrin Oppenheimer
Manager Registration
Responsibilities:
- Free Sales Certificates/Certificates of Marketability
- Marketing Media
- National Registration (Germany)
- National and International trade shows
Education/Experiences:
- Higher European Diploma in International Fair, Congress and Event Management
- Economic Assistant emphasizing Foreign Languages and Correspondence
- Design Assistant (GTA) Industrial design
- Language skills: German, English and Spanish
- Work experience in the USA and South Africa
Martina Meysing
Manager Registration
Responsibilities:
- National Registration (Italy)
Education/Experiences:
- International Diploma in Office Management ESA
- Language skills: German, Italian and English
- Work experience in Italy
Petra Bodonge
Manager Registration
Responsibilities:
- National Registration (Germany, Spain and Portugal)
Education/Experiences:
- Biological Laboratory Technician
- Language skills: German, Spanish, English and Portuguese
- Work experience in Spain, Portugal and Angola
Ulrike Zeglin
Consultant Vigilance
Responsibilities:
- MDD, IVDD and AIMDD Vigilance Reporting
Education/Experiences:
- Tradeswoman for business communication
- Language skills: German and English
Sophie - Canan Kurt
International Management Assistant
Responsibilities:
- Accounting
- Monitoring & processing of inquiries through to signing of contract
- Product Liability Insurance Certificate and Contractual matters
- Human Resources
- Office Administration & Correspondence
Education/Experiences:
- Higher European Diploma in International Tourism
- Economic Assistant emphasizing Foreign Languages and Correspondence
- Language skills: German, English and French
- Work experience in the USA and Spain
Karolina Tarapata
Administrative Assistant
Responsibilities:
- Office Administration & Correspondence
- Product Liablilty Insurance Certificate
Education/Experiences:
- University of Hamburg, Master of Arts degree in Linguistics - Eastern and Western Slavonic Languages
- London Chamber of Commerce and Industry Level 3 Certificate (English for Business)
- Language skills: German, English, Polish, Russian and Italian
Radostina Kamenova
Consultant
Responsabilities:
- MDD, IVDD and AIMDD Vigilance Reporting
- National Registration (Germany, Spain and Portugal)
Education/Experiences:
- International Communication and Translation, Bachelor of Arts, University of Hildesheim
- Language skills: Bulgarian, German, English, Spanish
- Studies abroad at the University of Oviedo, Spain