| • | The Team |
The MediTech team is comprised of a highly qualified group which includes:
  | VP of Business Development, based in the U.S.
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| Senior Project Managers
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| Clinical Research Associates
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| Regulatory and Quality Specialists
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| Financial Specialists
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| Administrative Coordinators |
Our experience includes work in the following therapeutic areas, but is not limited to: Cardiology, Cardiovascular, Peripheral Vascular, Dialysis, Endoscopy, Gastroenterology, Gynecology, Hemodynamics, Intensive Care, Oncology, Opthalmology, Orthopedics, Pulmonology, Spine, Urology and Vascular Surgery.
All of our clinical team is trained in Good Clinical Practices (GPCs) and ISO 14155 and can work with your investigational centers to ensure that your clinical data acceptable worldwide.
| • | Carla Kikken-Jussen (President & CEO) |
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Carla Kikken-Jussen has been working in Medical Device Technology for almost 25 years. She holds a bachelor degree in law and has extensive experience in the clinical and regulatory field. Carla is working with Technical Committees and Working Groups of the European Commission in various areas (CEN-TXC-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).
She is a board member of the Life Sciences Group Limburg.
E-mail: ckikken(at)meditech.nl
| • | Roy Lohmann (Executive to the President) |
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Roy Lohmann is Executive to the President. He holds a bachelor degree in international business administration, with several years of work experience in international business and finance. His former position at MediTech was Manager Finance Department, in which he was responsible for internal- as well as client related financial matters. He was in charge of handling administrative, legal and financial matters for MediTech's US office. In addition, Roy provided assistance in Business Development. As Executive to the President, Roy's responsibility is providing organisational and operational support to the President, as well as acting as client-point-of-contact on behalf of the President. He is also responsible for the day-to-day operations of the Administrative Department.
E-mail: rlohmann(at)meditech.nl
| • | René Roncken (VP Regulatory & Quality Services) |
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René is a highly experienced, motivated and competent employee with over 20 years experience in quality management systems and over 10 years experience in Regulatory Affairs of medical devices. He has worked in several areas of biochemistry, microbiology and medical devices. He has worked on quality management systems as well as regulatory submissions of medical devices as outlined in the European, FDA and GHTF guidelines, Medical Device Directive, FMA according the Pharmaceutical Affairs Law.
He is experienced in the development, implementation, maintenance and auditing of quality management systems at several European and US companies and production facility in Asia according to ISO 9001, ISO 13485 and 21 CFR Part 820. He has experience with CE marking, preparing Technical Files, 510(k) clearance of medical devices and regulatory & quality consulting.
He is senior member of American Society for Quality (ASQ) and member of Regulatory Affairs Professionals Society (RAPS).
E-mail: rroncken(at)meditech.nl
| • | Diana Espinoza, (VP of Business Development US) |
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Diana Espinoza, RAC, holds a bachelor degree in Clinical Science, and her experience includes work as a Registered Respiratory Therapist (primarily in Critical Care Medicine). Diana has 15 years experience in the Medical Device Industry, working in Clinical Research and Regulatory Affairs.
Her international clinical research background includes strategic planning, study design and execution, and project management.
E-mail: despinoza(at)meditech.nl
| • | Sandra Hahn (Director Finance Department) |
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Sandra Hahn, MediTech's Director of the Finance Department, has over 15 years of experience in finance and administration, within the medical device industry. Sandra's financial responsibilities include the management and coordination of the Finance Department, and the handling of all internal finance issues (including internal contracts), client-related financial issues and billing, and proposals and agreements with clients.
E-mail: shahn(at)meditech.nl
| • | Carin Wensing (Manager CRA Department) |
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Carin Wensing is a Senior Clinical Research Associate and holds a master degree in Health Sciences. She has a research background with experience in interventional studies and has almost 10 years of experience in the medical device industry. Carin has experience with, and participated in several European and International Clinical Multi-centre Studies. Her European clinical/regulatory experience includes the fields of neurology, cardiology, cardiovascular, urology, pulmonology and spine. As a CRA, her work in the EU also includes Ethics Committee submissions (IRB's), competent authority notification, site initiations, monitoring and close out visits.
E-mail: cwensing(at)meditech.nl
| • | Robin Lucchesi (Senior CRA and Project leader) |
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Robin is a Senior Clinical Research Associate with more than 7 years of experience in the medical device industry. He has been working with various types and classes of devices and has experience with data management systems, electronic CRF’s and statistical analysis for clinical data. Robin has a background of research and development and has been involved in the development and maintenance of quality systems according to the ISO 9001, ISO 13485 and 21CFR Part 820 and for the medical device industry to obtain the CE mark and FDA approval.
E-mail: rlucchesi(at)meditech.nl
| • | Patrick Simons (Senior CRA and Project leader) |
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Patrick is a Senior Clinical Research Associate with more than 5 years experience in the device industry. He has worked on various multi-centre studies. Throughout Europe on the regulatory submissions as well as on site monitoring.
Patrick is involved in Ethics Committee Submissions, Competent Authorithy Notifications and obtaining insurances for several projects.
E-mail: psimons(at)meditech.nl
| • | Hernàn Castro (CRA - Clinical Specialist) |
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Hernán is a Clinical Research Associate and Clinical Specialist with 10 years experience in public health and experience in the device industry and he has a medical background. He has worked on various multi-centre studies at MediTech. He is involved in Ethics Committee and Competent Authorities Submissions for several projects throughout Europe.
As a Technical Advisor and Operational Manager, he has been involved in various health care projects in South America for several years such as implementation of health care programs, technical training tool, and medical writing for projects.
E-mail: hcastro(at)meditech.nl
| • | Ramon Pikaart (CRA - Clinical Specialist) |
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Ramon Pikaart is a Clinical Research Associate and Clinical Specialist. He holds a Master Degree in Biomedical Engineering and a Bachelor Degree in Mechanical Engineering. Ramon has experience with clinical research in the gastroenterology, cardiovascular, cardiology, ophthalmology, neurology, obesity and aesthetics field. Ramon monitors EU clinical trials, takes care of Ethics Committee submissions (IRB's) as well as Competent Authority notifications. His work in the EU also includes Site Initiations, Monitoring and Close Out visits according to ISO 14155.
E-mail: rpikaart(at)meditech.nl
| • | Didier Billy (CRA - Clinical Specialist) |
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Didier Billy is a Clinical Research Associate and Clinical Specialist. Didier has nine years of applied academic life science experience (i.e. Ph.D. study, and Postdoctoral Research Fellowship) and eight years of experience in the medical device industry. Didier's experience in Research & Development includes the design and execution of laboratory experiments and in-depth analysis of data. His medical device experience includes pre-clinical and clinical work in cardiology, cardiovascular, vascular, spine, orthopaedics, wound management and cellular and drug-release therapy.
E-mail: dbilly(at)meditech.nl
| • | Mark Mommers (CRA) |
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Mark Mommers is a Clinical Research Associate. He has over 8 years experience in Project Coordinating as a Clinical Study Assistant. He has experience with clinical research in the Cardiovascular, Ophtalmology and Spinal field. His work in the EU also includes Site Initiations, Monitoring and Close Out visits according to ISO 14155. Mark has, and is working in EU clinical trials, takes care of Ethics Committee submissions (IRB's) as well as Competent Authority notifications.
E-mail: mmommers(at)meditech.nl
| • | Fiona Fransen (CRA) |
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Fiona Fransen is a Clinical Research Associate at MediTech. She has a background in human health and animal sciences. She has worked on various multi-centre studies throughout Europe on the regulatory submissions and has experience in the Aesthetic, Ophthalmology, and Cardiovascular field. Her work in the EU also includes Site Initiations, Monitoring and Close Out visits according to ISO 14155. Fiona has, and is working in EU clinical trials, takes care of Ethics Committee submissions (IRB's) as well as Competent Authority notifications.
E-mail: ffransen(at)meditech.nl
| • | Nathalie Socard (CRA) |
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Nathalie Socard is a Clinical Research Associate (CRA) at MediTech. She holds a Master’s Degree in Public Health and Environmental & Occupational Health. Previously, Nathalie worked as a Research Assistant on various multi-center studies in Canada and throughout the EU. Nathalie has experience in Oncology, Toxicology, and Bariatric Medicine. As a CRA, her work in the EU includes Ethics Committee submissions (IRBs), Competent Authority notifications, Site Initiations, Monitoring and Close-out Visits, all conducted in accordance with ISO 14155.
E-mail: nsocard(at)meditech.nl
| • | Frank Keulen (CRA) |
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E-mail: fkeulen(at)meditech.nl
| • | Nimet Tasar (CRA) |
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| • | Francisco Javier Diaz Molina (CRA) |
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| • | Piotr Witkowski (CRA) |
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E-mail: pwitkowski(at)meditech.nl
| • | Lisan Habets (Project Assistant) |
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MediTech’s Secretary CRA Department. Lisan has worked on various Medical Device multi-centre studies throughout Europe. She is involved in Ethics Committee Submissions and Competent Authorities Notifications for several projects. She also has experience with Project Management, Data Management, Stock Management, Business Development, EU registration according to Cosmetic Directive, EU Food Regulations, Class I Self-certification/notification, Vigilance Reporting.
E-mail: lhabets(at)meditech.nl
| • | Natascha de Jong (Secretary CRA Department) |
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E-mail: ndejong(at)meditech.nl
| • | Saskia Leufkens (Secretary CRA Department) |
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E-mail: sleufkens(at)meditech.nl
| • | Marlou Berbers (Quality Assurance Engineer) |
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Marlou Berbers is a Quality Assurance Engineer at MediTech Strategic Consultants B.V.. She holds a Master Degree in Business Administration and is specialized in Marketing. Marlou has experience with projects in the areas of In Vitro Fertilization and Culture Media. She is familiar with the regulatory affairs of medical devices and ISO 9001 & ISO 13485. Within MediTech Strategic Consultants B.V. she is responsible for regulatory and quality projects according to (inter)national standards, maintaining the quality management system to applicable ISO and FDA standards, document control and vigilance reporting support.
E-mail: mberbers(at)meditech.nl
| • | Benjamin Tarraf (Senior Financial Assistant) |
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Benjamin Tarraf is Senior Financial Assistant with several years of work experience in international business and finance. Benjamin is responsible for internal- as well as client related financial matters. He is also responsible of handling administrative, legal and financial matters for MediTech's US office.
E-mail: btarraf(at)meditech.nl
| • | Susanne Wolff (Financial Assistant) |
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With an administrative background, Susanne provides support with the client's contract, budget proposals and administration. In addition, she is responsible for the accounting part of MediTech Strategic Consultants.
E-mail: swolff(at)meditech.nl
| • | Maurice Delnoije (Financial Specialist) |
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Maurice is Assistant Finance Department. He is experienced in continuously supervising and updating systems in the financial organization and internal control systems. He provides detailed business development prognoses.
E-mail: mdelnoije(at)meditech.nl
| • | Jurgen Maassen (Financial Assistant) |
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Jurgen is Assistant Finance Department with experience in the financial and administrative field. Jurgen provides support with all client related billing as also the internal finance administration.
E-mail: jmaassen(at)meditech.nl
| • | Steffen Daalman (Financial Assistant) |
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Steffen Daalman is Financial Assistant at the Finance Department. He holds a Master Degree in Financial Management, a Master Degree in Strategic Management, and a Bachelor Degree in Business Administration. Steffen is responsible for client related agreements, proposals and other financial issues.
E-mail: sdaalman(at)meditech.nl
| • | Ingrid Hofstede (Secretary) |
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Ingrid is Secretary and has more than 20 years experience in administration dealing with issues of a confidential nature. In addition to assisting MediTech Management, Ingrid is responsible for providing oversight to the Administration department, archiving client project-related documentation and assisting in providing administrative support required.
E-mail: ihofstede(at)meditech.nl
| • | Mandy van Haaren (Secretary) |
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Mandy is Secretary and has experience in the administrative field in departments with confidential data. Besides providing any administrative support, she is responsible for archiving client project related documentation, preparing complete travel arrangements and assisting the CRA Department.
E-mail: mvanhaaren(at)meditech.nl
| • | Diana Coenjaerds (Adminstrative Assistant) |
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Diana is Administrative Assistant and has experience in the administrative field in departments with confidential data. Besides providing any administrative support, she is responsible for archiving client project related documentation, preparing complete travel arrangements and assisting the CRA Department.
E-mail: dcoenjaerds(at)meditech.nl
| • | Florence Schaefer (Administrative Assistant) |
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Florence is our Administrative Assistant and has experience in the administrative field in departments with confidential data. Besides providing any administrative support, she is responsible for archiving client project related documentation, preparing complete travel arrangements and assisting the CRA Department.
E-mail: fschaefer(at)meditech.nl
| • | Theo Jussen (Office Assistant) |
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Theo is our Office Assistant. Besides providing any administrative support, he is responsible for the delivery of your product shipments and takes care of transportation of guests and MediTech's employees.
E-mail: tjussen(at)meditech.nl
| • | Jean (J.J.J.) Theuns (Human Resources Manager) |
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| • | ASSOCIATE CRA's |
| • | Carolina Gualtieri - Italy |
Carolina is an experienced Clinical Research Associate and is experienced in regulatory submissions for clinical trials. We work together on joint projects over many years. Carolina has been extensively involved in multi-center European studies covering various therapeutic areas. These included endoscopy, gastor-enterology, gyneacology, haemodynamics, cardiology, intensive care, dialysis and orthopaedics.
| • | Valérie Neyt - France |
Valérie is an experienced Clinical Research Associate and is experienced in regulatory submissions for clinical trials. Valérie has been extensively involved in multi-center European studies covering various therapeutic areas.
| • | Alix Peslerbe - France |
Alix is an experienced Clinical Research Associate and is experienced in regulatory submissions for clinical trials. Alix has been extensively involved in multi-center European studies covering various therapeutic areas.
| • | Amit Korner - Israel |
Amit is an experienced Clinical Research Associate and is experienced in regulatory submissions for clinical trials. Amit has been extensively involved in multi-center European studies covering various therapeutic areas
| • | Ilana Fishman - Israel |
Ilana is an experienced Clinical Research Associate. Ilana has been extensively involved in multi-center European studies covering various therapeutic areas.
| • | Silke Flohr-Roese - Germany |
Silke is an experienced Clinical Research Associate. She has been extensively involved in European studies covering various therapeutic areas.
| • | Roger Dallwig - Germany |
Roger is an experienced Clinical Research Associate. He has been extensively involved in European studies covering cardiovascular therapeutic area.
| • | Petr Vaculik - Eastern Europe |
Petr is an experienced Clinical Research Associate and is experienced in regulatory submissions for clinical trials. He has been extensively involved in multi-center European studies covering various therapeutic areas.
| • | Maciej Wachulec - Poland |
Maciej is an experienced Clinical Research Associate. He has been extensively involved in European studies covering various therapeutic areas.