The evaluation of the long-term safety and performance of regulated medical devices, particularly class III, in the real world is foundational to sustained patient access to novel medical devices. With an increased focus on medical devices safety have contributed to new and evolving regulatory and methodological frameworks (MDR 2017/745) to improve data-driven risk assessment and management, surveillance and the safe use of regulated medical devices.
Our full suite of post-market clinical follow-up trials solutions are aligned with regulatory frameworks in the U.S. and Europe and can be customized to help you satisfy your clinical evidence generation needs and requirements.
ECLEVAR combines the latest insights, expertise and technology to design and optimize PMCF protocols, recruit clinicians and patients, and drive transparent communication. Combined with our hospitals partners and expertise in budgets, sites, and study management, our approach ensures each solution is optimized for device research, so you stay on time and on budget.
ECLEVAR combine expert, expertise and capabilities in medical device clinical trials areas. With our strategic partnership with hospitals, activating sites and finding the right patients was never been straightforward then ever.
to help our clients bring safer medical devices to patients.
Case-control, Cohort and other observational studies to assess the long-term treatment durability and safety studies in the real-world.
Generate clinical evidence to address post-approval evidence gaps and meet regulator and payer requirements for post-marketing effectiveness and safety.
Study design and execution
ECLEVAR can provide you with data, and technology requirements for medical device and diagnostics. We leverage our data-driven intelligence solutions and experts to design the right research for your product, information by our insights.
Across the medical device life cycle
ECLEVAR concept to market solutions and services help you orchestrate efficient research and development processes and decisions. Our comprehensive, integrated solutions and services create a connected offering from pre-market development to post-market life cycle support.
Medical Device and Diagnostics Expertise
ECLEVAR maintains industry-leading medical device training and consulting programs. We hire and train technology, clinical, and regulatory experts that are fully dedicated to medical devices. In turn, they receive ongoing operational support from project managers and study monitors dedicated to medical device and diagnostics projects.
Armêl PLAINE-Head of clinical operations
Armêl Plaine is an expert with over 10 years of experience in regulation of EU clinical investigations of medical devices. Following positions in MedPass’ clinical operations department, she moved to Regulatory Affairs and was appointed as manager in 2017. She personally has played a leading role for obtaining regulatory approvals for several significant EU trials of breakthrough medical technologies. Armêl holds a MSc in Biology from Düsseldorf University and a PhD in microbiology from AgroParisTech in Paris. She is fluent in German as well as English and French.