The leadership of Eclevar MedTech, a medical device CRO in Europe: a former Notified Body reviewer, senior clinicians, medical writers and biostatisticians with direct EU MDR Class III submission experience. The people on this page are the people on your project.
In the xShare x European CRO Federation (EUCROF) "EHDS & Clinical Research" Open Call, the top Platinum Award went to Milo Health, the Eclevar technology platform, presented at the EUCROF 2026 conference in Amsterdam.
Platinum Award · xShare Open Call for Clinical Research, organised by EUCROF and co-funded by the European Union. Amsterdam, 2 February 2026. Horizon Europe, Grant Agreement No. 101136734.
Eclevar is backed by private investors and venture capital. Learn about our investors
Senior experts who stay close to delivery. Your project is led by the names below, not handed to a junior account team.
Architect of Eclevar's therapeutic departments and global corridors.
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Cardiac surgeon, former Notified Body reviewer (TUV SUD).
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Specialist in Class III implants, PMCF programmes and CERs.
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CER methodology, traceability matrices, Article 61(4) equivalence.
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30 years in biometry. Architect of the MILO EDC platform.
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Drives clinical project delivery and site monitoring across Europe.
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Your first contact for scoping calls and partnerships.
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Financial stewardship of the group and its clinical programmes.
Tokyo operations, PMDA submissions and Foreign Manufacturer Accreditation.
Chems identified a critical gap: manufacturers needed a partner who understood both clinical reality and the strict expectations of European regulators. He architected Eclevar's therapeutic departments, piloted MILO EDC, and established global regulatory corridors from the EU to Japan (PMDA).
"Our mission is to bridge the gap between operational reality and Notified Body requirements."
Cardiac surgeon and former senior reviewer at a Notified Body (TUV SUD). He leads regulatory strategy with first hand experience of Notified Body questioning cycles and structures technical files for high risk devices (Class III). His anticipatory methodology systematically reduces Notified Body review cycles, accelerating time to market.
"A successful submission is won before it is filed by anticipating every reviewer's question."
Specialist in Class III implants. He builds PMCF programmes and CER reports designed around the way a reviewer reads a clinical file, with the evidence architecture argued from the first page.
"We build evidence that leaves the reviewer no other option but to approve."
Expert in clinical evaluation methodology for cardiovascular devices and complex implants. His specialty: building traceability matrices and Article 61(4) equivalence architectures that survive Notified Body review.
"We structure CERs as the reviewer needs to read them. Traceability is the key."
30 years of experience in biometry. Lead architect of MILO EDC and co-author of the EU MDR biometric activities framework. Expert in 21 CFR Part 11 compliance and FDA/EMA inspection readiness.
"Data integrity is the foundation of clinical evidence."
Charline leads the delivery of clinical investigations and PMCF studies across Europe: site qualification, investigator training, monitoring and Trial Master File maintenance, with the operational discipline that keeps multi-centre studies on schedule and inspection-ready. With a Master's in Health Engineering (Université Grenoble Alpes) and a background spanning clinical research, cardiovascular study management and medical device usability engineering, she bridges clinical operations and ISO 14155:2020 compliance at site level.
Karina is the first point of contact for sponsors and partners. She scopes new programmes with manufacturers, connects each project to the right Eclevar experts, and represents the team at conferences across Europe. If you book a call, you start with her.
He leads operations in Tokyo and bridges the gap between European MDR requirements and Japanese PMDA expectations. Expert in Foreign Manufacturer Accreditation.
He supervises our ISO 13485:2016 certified QMS. His rigor ensures that every study and dataset is audit ready from day one.
Architect of MILO EDC. He ensures cloud security and digital innovation to make structural non compliance impossible.
Where our consultants, including our former Notified Body expert, are presenting and what we are building. Come and find us, or book a call.
The Eclevar team, including our former Notified Body expert, on what cardiovascular trials need to satisfy Notified Body review.
Book a meeting ↗
Prof. Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on EU MDR and the introduction of new devices.
See the session ↗
Our award winning platform reads a protocol and returns three costed scenarios (swift, base, conservative) plus a recruitment forecast.
Explore the platform ↗Yes. Prof. Mark DaCosta, COO and CMO Cardiovascular, is a cardiac surgeon and former senior reviewer at a Notified Body (TUV SUD). He leads regulatory strategy with first hand experience of Notified Body questioning cycles.
The people on this page. Eclevar deliberately keeps senior experts close to delivery: clinical strategy, medical writing, biometry and operations are led by the executives themselves, not handed to junior account teams.
Karina Schonborn, Head of Partnerships, is the first contact for scoping calls and new partnerships. Write to clientcare@eclevar.com and she will set up a call with the right experts for your device.
Yes. The team has direct EU MDR Class III experience across cardiovascular, orthopaedic and implantable devices, including technical file structuring, CER methodology, PMCF programmes and Notified Body Q&A cycles.
Yes. Kazuo Watanabe leads operations in Tokyo and bridges European MDR requirements with Japanese PMDA expectations, including Foreign Manufacturer Accreditation.
Tell us about your device. Karina will set up a scoping call with the right experts from this page.
Book a free scoping call