European medical device CRO
Clinical investigations, PMCF and EU MDR evidence for complex medical devices
Eclevar designs and delivers European clinical programs, from evidence strategy and site execution through to data management, biometrics and clinical evaluation.
Medical devices only. Programs led by clinicians, former Notified Body reviewers and medical-device clinical operations specialists, within one accountable delivery model.
Selected client programs
- Meril Life Sciences
- RegenLab
- Perouse Medical, Vygon Group
- JRI Orthopaedics
- Nihon Kohden
30+Clinical programs delivered
2,000+Participants across clinical programs
Former Notified Body review experienceWithin Eclevar's clinical leadership
Platinum Award, Clinical Research Open Call 2026Awarded in the xShare and EUCROF Open Call, co-funded by the European Union.
What the award recognized
The Platinum Award recognized the clinical-research use case submitted to the xShare and EUCROF Open Call. It is not a ranking of contract research organizations and does not cover the full Eclevar service portfolio.
Where to start
How Eclevar can help
Start with the evidence question or delivery challenge your program needs to solve.
Clinical investigations
- Clinical and regulatory strategy
- Protocol and endpoint design
- Study start-up, monitoring and reporting
PMCF studies and registries
- PMCF strategy and study design
- Prospective, retrospective and registry models
- European site operations and PMCF reporting
Data management and biometrics
- EDC and eCOA
- Clinical data management and data quality
- Biostatistics and analysis datasets
Clinical evaluation and regulatory evidence
- Clinical evaluation strategy and CER
- Literature review and state of the art
- PMCF documentation and deficiency support
Client programs
Programs that show how Eclevar works
Two programs shown in depth because they demonstrate contrasting evidence architectures, then three that show breadth across other evidence models.
Meril Life SciencesStructural heart · Comparative clinical investigation · United Kingdom
Comparative clinical evidence across three contemporary TAVI valve platforms
3Valve platforms compared
1Prospective randomized UK study
4Comparative evidence domains
Challenge. Generate comparative clinical, quality-of-life and health-economic evidence across three valve platforms within one study rather than three.
Eclevar's role. Clinical program delivery and evidence coordination, including UK site delivery, data management and reporting.
Manufacturer names, trademarks and product images identify the valve platforms evaluated in the study. They do not imply endorsement of Eclevar by, or affiliation with, Meril Life Sciences, Edwards Lifesciences or Medtronic.
View the comparative TAVI program
European PMCF evidence across two chronic-wound populations
160Participants
14Clinical sites
2Wound populations, DFU and VLU
Challenge. One post-market program covering two clinically distinct wound populations, with endpoints that serve both Notified Body scrutiny and reimbursement discussions.
Eclevar's role. Full program delivery from protocol design to final study report, with European site coordination and structured capture in Milo Studio.
Selected programs across other evidence models
Portfolio-level post-market evidence, pre-market investigation architecture and clinical evaluation delivered as a documentation package.
View the program architecture
Perouse Medical, Vygon Group
Vascular devices · Portfolio post-market evidence
Consistent post-market clinical evidence across three implantable device families, under one evidence model rather than three unconnected designs.
6Registered observational studies
3Device families in scope
View the program architecture
JRI Orthopaedics
Orthopedics · Pre-market clinical investigation, in progress
One investigation covering early safety and performance and, in a second connected part, long-term implant survivorship and radiographic assessment.
2Connected program parts
4Planned evidence domains
View the program architecture
Nihon Kohden
Neurological diagnostics · Clinical evaluation package
A defensible clinical evidence package for a diagnostic neurophysiology system, built from existing evidence rather than from new study operations.
5Verified scope items delivered
5Stages to CER integration
Therapeutic expertise
Specialist clinical evidence across complex device categories
Cardiovascular and structural heart
Comparative performance and follow-up that has to stay credible for years, across TAVI, structural heart and imaging-based endpoints.
ProofComparative TAVI evidence across three contemporary valve platforms.
Explore cardiovascularOrthopedics, spine and surgical robotics
Survivorship, revision and registry evidence carry the argument for joint replacement, spinal implants and robotic-assisted surgery.
ProofTwo-part clinical investigation architecture for a ceramic hip resurfacing system.
Explore orthopedics and spineNeuromodulation
Class III expectations, specialist populations and long follow-up meet small recruiting pools in implantable neurostimulation.
ProofClinical and PMCF strategy supporting a Class III implantable neuromodulation program.
Explore neuromodulationAdvanced wound care
Wound closure, healing endpoints and country variation in standard of care shape the design for DFU and VLU populations.
ProofEuropean PMCF program across two chronic-wound populations and 14 sites.
Explore wound careDelivery model
One accountable delivery model from evidence strategy to regulatory submission
A clinical program is only as strong as the connections between its strategy, site execution, data and final regulatory documentation.
Pillar 01
Generate clinical evidence
- Clinical and regulatory strategy
- Protocol and endpoint architecture
- Country and site feasibility
- Monitoring and site management
Pillar 02
Convert data into defensible evidence
- EDC and eCOA
- Clinical data management and data quality
- Biostatistics and imaging endpoints
- Analysis datasets
Pillar 03
Integrate evidence into the product lifecycle
- Clinical Evaluation Plans and Reports
- Literature review and state of the art
- PMCF Plans and Reports
- Deficiency responses
The same team carries all five stages
- Clinical strategy
- European execution
- Data and biometrics
- Clinical reporting
- Regulatory evidence
European execution
European country, site and investigator feasibility
Country selection affects patient access, investigator experience, regulatory pathways, contracting timelines, standard of care and cost per participant.
- Operating entity
- In-house clinical delivery
- Selected market
Operating entity
United Kingdom
- Operating model
- Eclevar MedTech UK Ltd, with in-house clinical delivery and a resident UK site delivery lead.
- Site environment
- Established interventional and specialist centers, with investigator relationships in structural heart, orthopedics and wound care.
- Typical pathway considerations
- Depending on device status, intended use and study design, the pathway may involve MHRA notification, ethics review, HRA review and relevant NHS site approvals.
Operating entity
France
- Operating model
- Eclevar Healthtech SAS, with in-house clinical delivery and project leadership.
- Site environment
- University hospitals and private centers, with established investigator relationships in vascular and wound care.
- Typical pathway considerations
- Depending on device status and study design, the pathway may involve an ANSM authorization or notification, CPP review and site agreements.
In-house clinical delivery
Germany
- Operating model
- In-house clinical operations leadership for the DACH region. No German operating entity is currently registered.
- Site environment
- Large academic and specialist centers with high procedural volumes.
- Typical pathway considerations
- Depending on device status and study design, the pathway may involve competent federal authority requirements, ethics committee review and site contracts.
In-house clinical delivery
Italy
- Operating model
- In-house clinical delivery for Italian sites, run from the European delivery team.
- Site environment
- Regional and university centers with substantial interventional cardiology and orthopedic activity.
- Typical pathway considerations
- Depending on device classification, CE-marking status and study type, the pathway may involve authorization or notification, ethics review and the relevant national process.
Selected market
Spain
- Operating model
- Selected market with submission and delivery experience, run from the European delivery team.
- Site environment
- University hospitals with established device research activity.
- Typical pathway considerations
- Depending on device status and study design, the pathway may involve an AEMPS authorization or notification, CEIm review and site agreements.
Selected market
Nordic markets
- Operating model
- Selected markets, run from the European delivery team. Documented submission experience relates principally to Denmark.
- Site environment
- Centralized specialist centers with a strong registry and follow-up culture.
- Typical pathway considerations
- Nordic markets do not share one regulatory system. Country-specific competent authority and ethics requirements are confirmed for the selected Nordic country.
Program leadership
Senior experts accountable for your clinical and regulatory program
Our physician leadership includes practicing surgeons and former TÜV SÜD senior reviewers, working alongside senior clinical operations, data and medical-writing leaders.
Dr. Mark Da Costa
Chief Operating Officer and Head of Cardiovascular
Mark leads cardiovascular clinical and regulatory strategy, combining 25 years of consultant cardiac surgery experience with first-hand experience in senior Notified Body leadership and clinical review.
See the full profile
Dr. Nikhil Khadabadi
Chief Medical Officer, Orthopedics and Spine
Leads orthopedic, spine and surgical-robotics clinical strategy, combining current NHS orthopedic practice with first-hand Notified Body review experience in Class III implantable devices.
See the full profile
Charline Petitdemange
Project Delivery Lead, France and United Kingdom
Coordinates French and UK clinical programs from mobilization through close-out.
Sébastien Meier Piantanida
Chief Data Officer
Owns the frameworks used to collect, standardize and analyze clinical data.
Pierre-Marie Boutanquoi
Head of Medical Writing
Leads Clinical Evaluation Reports, PMCF documentation and deficiency responses.
Former positions are stated for biographical context only. Eclevar MedTech is independent and is not affiliated with or endorsed by TÜV SÜD. TÜV SÜD is a registered trademark of its respective owner.
Clinical technology
Clinical technology built around medical device evidence delivery
Milo Studio supports controlled clinical-data capture, monitoring, data-quality workflows and audit-ready evidence delivery across clinical investigations and PMCF programs.
- Study-specific EDC and eCOAControlled workflows and role-based access.
- Monitoring and data qualityQuery management and data-quality review across the dataset.
- Analysis-ready datasetsControlled exports that feed directly into clinical reporting.
Program proof. Used in RegenLab's European chronic-wound program, across both wound populations and all participating sites.
Publications and external evidence
Published work, client perspectives and industry collaboration
Published whitepaper
EU MDR post-market clinical follow-up: gaining real-world evidence
Written with the Notified Body BSI.
Read the BSI and Eclevar whitepaper
Client perspective
Running a European chronic-wound PMCF program
Antoine Turzi, Chief Executive Officer of RegenLab.
Watch the RegenLab interview on YouTube
Industry collaboration
EHDS and Clinical Research Open Call results
Announced by xShare and EUCROF, co-funded by the European Union.
Read the announcement on xshare-project.euStart a discussion
Planning a clinical investigation, PMCF program or EU MDR evidence strategy?
Share your device category, development stage, target countries and principal evidence question.
- Clarify the principal evidence gap and regulatory objective
- Identify suitable countries, sites and operational constraints
- Connect clinical delivery, data and final regulatory documentation
Talk to the clinical and regulatory team
The first call is with the people who would run the program.
Discuss your program