| • | MediTech's Team Members |
MediTech Strategic Consultants B.V. (MediTech) is a full service international Contract Research Organization (CRO) focused on Clinical, Regulatory and Quality Consulting and Authorized Representative services with a staff of more than 40 highly qualified team members comprised of:
  | Business Developers
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| Project Managers
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| (Senior) Clinical Research Associates
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| Clinical Specialists
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| Regulatory and Quality Specialists
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| Financial Specialists
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| Clinical Project Assistants
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| Administrative Coordinators |
MediTech’s team members extensive clinical, regulatory and quality experience is complemented by multilingual and cross cultural fluency. The multinational staff are based in The Netherlands HQ office with additional professionals in the Czech Republic, Israel and Poland who offer comprehensive support services to meet our client’s needs for clinical trials conducted throughout the European Union and Israel, Norway, Switzerland and Turkey. The MediTech team can provide all the clinical, regulatory and quality guidance and project support you require.
| • | Carla Kikken-Jussen, President & CEO |
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Carla Kikken-Jussen, President, CEO and Founder of MediTech Strategic Consultants B.V. established MediTech over a decade ago. Her over 25 years of experience in the medical device industry covers medical device clinical research and European Regulatory Affairs. Since 2000, Carla has brought hundreds of client’s medical devices and combination products to market in the European Union and Israel, Norway, Switzerland and Turkey as well as obtaining European clinical data that is acceptable to the FDA. Carla’s industry experience includes her work with the Technical Committees and Working Groups of the European Commission in various areas: CEN-TC-316 “Animal tissues and their derivatives utilized in the manufacture of medical devices”; CEN-BT-WG 132 “Methods for analysis of Allergens” and NEN-301-007 “Quality Systems for Body Materials”. She served on the board of the Life Sciences Limburg Group and is a member of the Dutch Standardization Institute (NEN), the Regulatory Affairs Professional Society (RAPS) European Advisory Committee, the Orange County Regulatory Affairs organization and Member of the WMDO Board of Certification for CMDA (Certified Medical Device Associate) clinical evaluation. In 2008 Carla was the first female to be awarded the Entrepreneur of the Year by Rabobank Demarrage and in 2010 was awarded the Best Woman Entrepreneur by the Dutch Federation of Businesswomen.
E-mail: ckikken(at)meditech.nl