• President of MDSS
• Safety Officer

• Over 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

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

• 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

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

• 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

• Regulatory Affairs Professional Society (RAPS)

• Regulatory Affairs Consulting
• Quality Management Consulting
• Safety Officer

• 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
• Language skills: German and English

Member of:

• Regulatory Affairs Professional Society (RAPS)

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

• 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"
• Language skills: German and English

Member of:

• Regulatory Affairs Professional Society (RAPS)

• Regulatory Affairs Consulting
• Quality Management Representative
  
  

• 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
• Language skills: German and English

• National Medical Device Registrations (Resposible for the team of National Registrations)
• MDD, IVDD and AIMDD Vigilance reporting

• 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

• Free Sales Certificates/Certificates of Marketability
• Marketing Media
• National and International trade shows

• 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

• National Registration (Italy)

• International Diploma in Office Management ESA
• Language skills: German, Italian and English
• Work experience in Italy

• National Registrations (Germany, Spain, France and Portugal)

• Biological Laboratory Technician
• Language skills: German, Spanish, English and Portuguese
• Work experience in Spain, Portugal and Angola

• MDD, IVDD and AIMDD Vigilance Reporting

• Tradeswoman for business communication
• Language skills: German and English

• Accounting
• Monitoring & processing of inquiries through to signing of contract
• Product Liability Insurance Certificate and Contractual matters
• Human Resources
• Office Administration & Correspondence

• 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

• National Registration (Germany)
• Office Administration & Correspondence
• Product Liablilty Insurance Certificate

• 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 Vigilance

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

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, German and English

Manager Registration

Responsibilities:

• National Registrations (Germany, Italy)
  
• Free Sales Certificates/Certificates of Marketability
  
• Product Liability Insurance Certificate
  
  

Education/Experience:

• Medical University Diploma, Semmelweis University of Medicine, Hungary (dr.med)
  
• Project Manager in Phase I Clinical Studies with Generic investigational medicinal products
• On-site Management Associate in Phase II-III Studies with medicinal products
  
• Language skills: German, Hungarian and English
  
• Work experience in UK and in Hungary