China's Best One-Stop Medical Equipment Provider
About

ECLEVAR is a Contract Research Organization (CRO) based in Paris, France, specializing in the medical device industry. Founded in October 2020, the company focuses on navigating the regulatory landscape for medical devices, particularly the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). ECLEVAR combines insights from regulatory authorities, industry experts, and CRO professionals to provide comprehensive clinical evaluation and regulatory support throughout the product lifecycle. The company offers a range of services, including clinical evaluation and regulatory consulting, premarket clinical trials, and post-market clinical follow-up (PMCF). ECLEVAR utilizes a cloud-based platform that enhances clinical trial design and execution, significantly reducing deployment timelines. Additionally, the company provides global regulatory support, catering to markets such as the UK, Germany, and Japan, ensuring compliance with local regulations. ECLEVAR serves medical device and in vitro diagnostic manufacturers, including leading global MedTech companies. Their innovative clinical trial platforms and regulatory expertise help clients bring advanced medical devices to market efficiently and safely.

Technologies
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Keywords
notified body support voice technology in trials medical device clinical evaluation report pharmaceuticals european mdr iso 14155 compliance mdr compliance consulting hybrid clinical studies risk management cer preparation medical device safety clinical evaluation report (cer) regulatory support data protection clinical data collection consulting clinical study design services patient reported outcomes (pros) clinical trial services real-world evidence pmcf studies clinical study site selection healthcare equipment & supplies manufacturing clinical trial management data privacy and ethics clinical data traceability b2b european vascular registry
Company Information
  • Employees 29
  • Founded 2020
Location

20 Avenue Andre Prothin, Courbevoie, Ile-de-France, France, 92400

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