MEDICAL DEVICE CRO FROM PREMARKET TO POST MARKET CLINICAL FOLLOW-UP (PMCF)
ECLEVAR MEDTECH is a unique CRO, it brings Competent Authority, notified body, industry and CRO expertise together to overcome your clinical evaluation (CER) , clinical trials and regulatory challenges.
Idil Gurkan Ozturk Global Clinical Project Delivery Manager |
20 years experienced Line Management and Clinical Project Delivery Management with a demonstrated history of working in the pharmaceuticals industry at both Pharmaceutical Company and CRO
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Yukako Oshima Clinical Research Consultant |
7 years’ working experience performing study-related document development, regulatory document collection, monitoring and clinical data review. Diligent in conducting studies aligned with good clinical practices, study-specific requirements and local regulations. |
Stéphanie Bengochea Senior CRA | Senior CRA :
Registred nurse, with 6 year’s experience in clinical research in Cardiovascular and urology studies. |
Pr.Yann Goueffic MEDICAL EXPERT REFERENT VASCULAR SURGEON | Scientific board member at ECLEVAR, referent endovascular and open procedures for peripheral arterial diseases-Professor of vascular surgery in the Vascular Center at Groupe Saint Joseph, Paris. -President of Clinical trial Unit at Groupe Hospitalier Paris Saint Joseph |
Pr. Luc Téot Medical Expert Wound Healing |
Pr. Luc Téot is the head of the Burns Unit and Wound Healing Unit of the Montpellier University Hospital in France. He is author of over 100 publications and wrote several books and book chapters.
He is an editorial board member of 8 journals and former president of the World Union of Wound Healing Societies and the European Tissue Repair Society.
He teaches as professor at the universities of Montpellier, Nantes, Limoges, Antilles and La Réunion. His passion for wound healing and scarring has encouraged him to become organiser of international conferences like Scar Club, Conférence de Plaies et Cicatrisation and the International Workshops on Wound Technology. Prof. Téot is qualified in General, Orthopaedic and Plastic surgery.
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Introducing MILO: Revolutionizing Healthcare with Personalized, On-Demand Care
MILO is a game-changer in the healthcare industry, providing patients with personalized, on-demand care that is both convenient and effective.
With MILO, patients can receive high-quality medical care without ever leaving their homes, saving time and money while reducing the risk of exposure to illness.
Milo allows you to conveniently and rapidly connect 24/7 with general doctors, nurses, and pharmacists through your device.
BALANCES REGULATORY, CLINICAL EVALUATION, AND BUSINESS RISKS AND OBJECTIVES
Competent authorities around the world exchanges information’s about your products risk and efficacy who put your business on stake. ECLEVAR MEDTECH can see your challenges from different angles for better support and understanding. From clinical reports to clinical data collection.
With an international team that encompass: Former Competent Authority/notified body experts, Clinical Evaluation and PMCF experts from the industry, Medical device CRO experts, Key opinions leader for better understanding of your products
If you want know more, Get In touch with OUR Global Chief commercial OFFICER:
Within 3 years, ECLEVAR delivered transformative solutions.
OUR MEDICAL DEVICE PARTNERS AND ASSOCIATIONS
A Regulators Perspective on Clinical Evaluations and Investigations
- A regulator’s thought on the new clinical evaluation requirements – does it solve the problem?
- What are the key challenges for the regulator in implementing the new requirements?
- The UK – a regulator with ‘two halves’. What are the implications for the UK, and what happens in 2023
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LATEST NEWS
Experienced CRO Solutions for EMA Compliance
What are the experienced CRO solutions available for Medical Device EMA Compliance? European Medicines Agency is the organ responsible for the assessment of quality and
Clinical Evaluation Report (CER): Everything You Need to Know
A Clinical Evaluation Report (CER) is a document that exposes a clinical assessment’s conclusions of a medical device. The report must provide evidence, that conveys
ECLEVAR MEDTECH Launches EU Medical Device Regulation Compliance Support Services for Japanese MedTech Manufacturers
ECLEVAR MEDTECH, a Paris-based global CRO, has announced that it will provide clinical trial services using the Oracle Clinical One platform to meet the needs
Medical Devices for Cardiac Arrhythmia Management: Clinical Applications and Evidence Requirements
The heart is a vital organ responsible for pumping blood throughout the body, ensuring oxygen and nutrients are delivered to and waste products are removed