The #1 European CRO for Medical Device trials
The European CRO run by clinicians and former Notified Body reviewers.
Eclevar Medtech wins
Platinum Award
for Clinical Research Excellence
Eclevar Medtech was awarded the Platinum Award at the xShare Open Call for Clinical Research, organised by EUCROF (European CRO Federation) and co-funded by the European Union. Recognised as the top-ranked CRO in Europe for innovation in clinical trials for medical devices.
End-to-end clinical execution
for medical devices.
We combine comprehensive clinical study and data management services with deep regulatory know-how and digital capabilities. Our focus is on several highly demanding therapeutic verticals.
Cardiovascular
Expertise in the most technically demanding Class III categories, including TAVI and other structural heart devices, guidewires and perivascular devices.
Orthopaedics & Spine
PMCF biometric architecture for joint reconstruction and spinal implants. Seamless implant registry integration (NJR, EPRD) and strict radiographic standardisation.
Neuromodulation
Annex IX/X clinical strategies for Class III active implants: SCS, DBS, and peripheral nerve devices. Built to manage complex 10-year follow-up requirements.
Advanced Wound Care
Strategic PMCF programmes and wound management for NPWT, bioengineered tissue, and antimicrobial dressings. Powered by EWMA collaboration and REDIT registry access.
Clinical Operations & PMCF
End-to-end execution from pre-market FIH studies to full PMCF registry studies. We manage ISO 14155:2026 protocol design, Ethics Committee approvals, and conduct rigorous site monitoring.
Data Management & Regulatory
21 CFR Part 11 compliant data capture via our proprietary MILO Studio platform. Combined with expert biostatistics, systematic CER authoring, and Notified Body-ready clinical evaluation.
The team behind your clinical trial and regulatory strategy.
Dr Mark DaCosta
Cardiac Surgeon and Former TÜV SÜD Senior Reviewer, with 30 years experience in structural heart devices.
Dr Nikhil Khadabadi
NHS Orthopaedic Surgeon and Former TÜV SÜD Senior Reviewer with Class III devices focus. Specialises in implantable device clinical evidence processes.
Charline Petitdemange
With over 15 years of experience, she oversees the operational execution of European clinical investigations and PMCF studies, ensuring full compliance with ISO 14155 and EU MDR standards.
Sébastien Meier
30 years experience in Biometrics. Currently serving as the Head of Data Management and Biostatistics.
A client's live testimonial on Eclevar's capability to run medical device clinical investigations.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomised study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
"ECLEVAR provides a unique, tailor-made approach; paired with the advanced MILO Studio platform, they are a major strategic asset for any device investigation."
5 EU countries
Watch the testimonial
Why manufacturers choose Eclevar
We are a purely specialist medical device CRO and MedTech consultancy built for European market access.
Headquartered in Dublin, Ireland and rooted in Europe, our teams operate from London, Paris and Tokyo: close to the clinical sites, the regulators and the Notified Bodies that decide your certification.
Manufacturers choose Eclevar because we have sat on the other side of the table. Our clinical leadership includes former Notified Body reviewers, among them a former TÜV SÜD senior reviewer with more than 400 devices CE certified. Every protocol, CER and PMCF plan is written as regulatory defence, built to withstand the review it will face.
The proof is operational: a 160 patient PMCF across 14 sites in 5 European countries for RegenLab, a 666 patient TAVI study across UK centres for Meril Life Sciences, and an ISO 13485:2016 certified quality system behind every dataset we lock.
We are known for our European expertise. When your path begins beyond it, our Tokyo office brings Japanese manufacturers into EU MDR with the same discipline.
Our services,
from design to market access.
Three departments. One connected evidence strategy. Click each department to unfold its services.
- Study design & protocols
- First-in-human & pivotal investigations
- PMCF studies, surveys & registries
- Monitoring & site management
- ISO 14155 compliance
- Clinical evaluation plans & reports (CEP / CER)
- Systematic literature reviews & SOTA
- PMCF plans & reports
- QMS implementation & audits
- SOP development
- Training
- Regulatory strategy (EU MDR & UK MDR)
- MDR gap assessment
- NB deficiency responses
- eCRF design & build
- Data review & cleaning
- Sample size & statistical analysis plans
- Statistical analysis & reports
MILO Studio: The EDC and Survey Clinical Evidence Platform
Every hour spent on manual data entry is an hour not spent on patients.
MILO Studio is built to automate the repetitive work, freeing clinical teams to focus where it matters most: verifying data quality and monitoring patient safety.
for Lifecycle Outcomes
Our content, signed Eclevar.
Whitepapers and publications produced with our partners and Notified Bodies (BSI, TÜV SÜD).
A BSI and Eclevar whitepaper on the EU MDR.
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any high risk device programme, active implants included.
Read the whitepaper
Coming soon
A TÜV SÜD whitepaper on clinical evidence under EU MDR.
Co-authored with a former TÜV SÜD senior reviewer: what Notified Bodies expect from your clinical evaluation and PMCF strategy for Class III and implantable devices.
Your pending Notified Body submission
should be the last one
with findings.
Whether you are designing a first PMCF programme, remediating a legacy EDC before re-certification, preparing for an inspection, or building IIS evidence for indication expansion, the Eclevar Medtech team delivers clinical strategy built for regulatory success.