European medical device CRO
Clinical investigations, PMCF and EU MDR evidence for complex medical devices
Eclevar designs and delivers European clinical programmes from evidence strategy and site execution through to data management, biometrics and clinical evaluation.
Programmes are led by clinicians, former Notified Body reviewers and medical-device clinical operations specialists within one accountable delivery model.
- Medical devices only
- European clinical delivery
- Former TÜV SÜD senior reviewers within the leadership team
- Clinical operations, data and reporting in one team
Selected client programmes
Meril Life Sciences
RegenLab- Perouse Medical, Vygon Group
JRI Orthopaedics
Nihon Kohden
- Former TÜV SÜD senior reviewersTwo members of the leadership team held senior review roles at TÜV SÜD.
- Published with BSIWhitepaper on post-market clinical follow-up under EU MDR.
- Medical device specialistNo pharmaceutical portfolio competing for the same teams.
- European operating modelOperating entities in France and the United Kingdom.
- ISO 14155-aligned deliveryStudy conduct, documentation and monitoring built to the standard.
About the Platinum Award and the former TÜV SÜD roles
The Platinum Award recognised the clinical-research use case submitted to the xShare and EUCROF Open Call, co-funded by the European Union. It is not a ranking of contract research organisations and does not cover the full Eclevar service portfolio. Former positions are stated for biographical context only: Eclevar MedTech is independent and is not affiliated with or endorsed by TÜV SÜD.
Where to start
How Eclevar can help
Start with the evidence question or delivery challenge your programme needs to solve.
Clinical investigations
- Clinical and regulatory strategy
- Protocol and endpoint design
- Feasibility and site selection
- Study start-up
- Monitoring and site management
- Clinical investigation reporting
PMCF studies and registries
- PMCF strategy
- Prospective PMCF studies
- Retrospective evidence programmes
- Registries
- European site operations
- PMCF reporting and clinical evaluation integration
Data management and biometrics
- EDC and eCOA
- Clinical data management
- Biostatistics
- Imaging and endpoint data
- Data-quality processes and analysis datasets
- Statistical reporting
Clinical evaluation and regulatory evidence
- Clinical evaluation strategy
- Systematic literature review
- State-of-the-art assessment
- Clinical-data appraisal
- CER and PMCF documentation
- Notified Body deficiency support
Selected client programmes
Five client programmes that show how Eclevar works
Real delivered or ongoing programmes showing how Eclevar connects clinical strategy, European execution, data and regulatory evidence across complex medical-device categories.
Structural heart · Comparative clinical investigation · United Kingdom
Ongoing programme
Meril Life SciencesSponsor of record
Comparative clinical evidence across three contemporary TAVI valve platforms
- Challenge
- Generate comparative clinical, quality-of-life and health-economic evidence across the Myval, Sapien and Evolut THV Series within one prospective randomised United Kingdom study.
- Eclevar's responsibility
- Clinical programme delivery and evidence coordination across the comparative study, including UK site delivery, data management and reporting.
- Material complexity
- Three valve platforms under a common assessment schedule, standardised imaging review, adjudicated clinical endpoints and health-economic data capture.
- Programme output
- Comparative 30-day evidence covering quality of life, clinical and safety outcomes, echocardiographic outcomes and health-economic analysis.
Manufacturer names, trade marks 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.
Advanced wound care · European PMCF programme
RegenLabSponsor of record
European PMCF evidence across diabetic foot ulcer and venous leg ulcer populations
- Challenge
- One post-market programme covering two clinically distinct wound populations, DFU and VLU, with endpoints that serve both Notified Body scrutiny and reimbursement discussions.
- Eclevar's responsibility
- Full programme delivery, from protocol design to final study report, with European site coordination and structured capture in MILO Studio.
- Material complexity
- 160 participants and 14 clinical sites, European sites including the United Kingdom, two wound populations and one standardised pathway.
- Programme output
- Post-market clinical follow-up evidence across both wound populations.
"ECLEVAR provides a unique, tailor-made approach; paired with the advanced MILO Studio platform, they are a major strategic asset for any device investigation."
Vascular devices · Portfolio PMCF
Perouse Medical, Vygon GroupRetrospective observational programme
One PMCF evidence programme across the Perouse Medical vascular portfolio
- Challenge
- Generate consistent post-market clinical evidence across vascular patches, vascular prostheses and implantable ports without three unconnected study designs.
- Eclevar's responsibility
- Design and delivery of six registered retrospective PMCF studies, with a common safety structure, post-implantation clinical follow-up and harmonised data and reporting.
- Material complexity
- One harmonised evidence model applied across six studies and three device families, holding device-family evidence and portfolio-level consistency together.
- Programme output
- Clinical safety and performance evidence supporting EU MDR clinical evaluation and PMCF.
Orthopaedics · Pre-market clinical investigation
Programme in progress
JRI OrthopaedicsDevice developer and owner
Two-part clinical investigation for a ceramic hip resurfacing system
- Challenge
- Design one investigation covering early safety and performance and, in a second connected part, long-term implant survivorship, function and radiographic assessment.
- Eclevar's responsibility
- Clinical investigation architecture: synopsis, objectives and endpoints, visit and imaging design, long-term follow-up planning, PROM and Milo ePRO integration, external comparator and statistical methodology.
- Material complexity
- Part 1 covers early safety, initial performance, imaging and hip function. Part 2 covers implant survivorship, revision outcomes, longitudinal imaging, long-term function, PROMs and metal-ion surveillance, with a registry-derived external comparator.
- Programme output
- Clinical evidence architecture supporting EU MDR clinical evaluation and PMCF, with imaging follow-up, PROMs and function, safety and revision events and long-term survivorship as the planned evidence domains.
Neurological diagnostics · Clinical evaluation
Nihon KohdenNeurological diagnostic device programme
EU MDR clinical evidence for a neurodiagnostic system
- Challenge
- Build a defensible clinical evidence package for an electromyography and evoked-potential system, a diagnostic clinical-neurophysiology platform rather than a therapeutic device.
- Eclevar's responsibility
- Clinical evaluation strategy, Clinical Evaluation Report, systematic literature review, state-of-the-art assessment and clinical-data appraisal.
- Material complexity
- A five-stage pathway: existing clinical evidence, state of the art, clinical performance and safety, post-market evidence planning, then CER integration.
- Programme output
- Clinical evidence package prepared for conformity assessment under EU MDR. No certification or conformity-assessment outcome is attributed to Eclevar.
Therapeutic expertise
Specialist clinical evidence across complex device categories
Each area has its own evidence problem: comparators, follow-up horizons, imaging, registries or software performance. Start where your device sits.
Cardiovascular and structural heart
TAVI, structural heart, cardiovascular implants and imaging-based endpoints, where comparative performance and long-term follow-up decide whether the evidence holds.
Proof of experienceComparative TAVI evidence across three contemporary valve platforms.
Explore cardiovascular programmesOrthopaedics, spine and surgical robotics
Joint replacement, spinal implants, instrumentation and robotic-assisted surgery, where survivorship, revision, imaging and registry evidence carry the argument.
Proof of experienceTwo-part clinical investigation architecture for a ceramic hip resurfacing system, from early safety through long-term survivorship.
Explore orthopaedic and spine programmesNeuromodulation
Implantable neurostimulation systems, leads and programming software, where Class III expectations, specialist populations and long follow-up meet small recruiting pools.
Proof of experienceClinical and PMCF strategy supporting a Class III implantable neuromodulation programme.
Explore neuromodulation programmesAdvanced wound care
Diabetic foot ulcer and venous leg ulcer populations, where wound closure, healing endpoints, imaging and country variation in standard of care shape the design.
Proof of experienceEuropean PMCF programme across two chronic-wound populations and 14 sites.
Explore wound care programmesDelivery model
One accountable delivery model from evidence strategy to regulatory submission
A clinical programme 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
- Clinical investigations
- PMCF studies and registries
- Monitoring and site management
Pillar 02
Convert data into defensible evidence
- EDC and eCOA
- Clinical data management
- Biostatistics
- Imaging and endpoint data
- Query processes and data-quality review
- Analysis datasets
Pillar 03
Integrate evidence into the product lifecycle
- Clinical Evaluation Plans and Reports
- Systematic literature review and state of the art
- PMCF Plans and Reports
- Clinical investigation reports
- Deficiency responses
- Regulatory and quality strategy
- Stage 01Clinical strategy
Evidence gap, endpoints and regulatory objective.
- Stage 02European execution
Country and site feasibility, start-up and monitoring.
- Stage 03Data and biometrics
EDC and eCOA, data quality and analysis datasets.
- Stage 04Clinical reporting
Statistical output and clinical investigation reports.
- OutputRegulatory evidence
CER, PMCF documentation and conformity dossier.
The same programme team carries the study from endpoint design through to the documents that enter the conformity-assessment dossier.
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.
Select a market to read its operating model. Without JavaScript, all six markets are shown in sequence below.
- 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 and investigator environment
- Established interventional and specialist centres, with investigator relationships in structural heart, orthopaedics and wound care.
- Regulatory pathway
- MHRA notification with HRA and research ethics committee approval.
- Feasibility focus
- Centre access, contracting timelines and variation in standard of care between trusts.
Operating entity
France
- Operating model
- Eclevar Healthtech SAS, with in-house clinical delivery and project leadership.
- Site and investigator environment
- University hospitals and private centres, with established investigator relationships in vascular and wound care.
- Regulatory pathway
- ANSM authorisation with CPP ethics committee approval.
- Feasibility focus
- Site contracting, ethics timelines and cost per participant.
In-house clinical delivery
Germany
- Operating model
- In-house clinical operations leadership for the DACH region. No German operating entity is currently registered.
- Site and investigator environment
- Large academic and specialist centres with high procedural volumes.
- Regulatory pathway
- BfArM authorisation with ethics committee approval.
- Feasibility focus
- Investigator availability, contracting and budget negotiation at high-volume centres.
In-house clinical delivery
Italy
- Operating model
- In-house clinical delivery through a resident lead clinical research associate.
- Site and investigator environment
- Regional and university centres with substantial interventional cardiology and orthopaedic activity.
- Regulatory pathway
- Ministry of Health notification with ethics committee approval.
- Feasibility focus
- Regional variation in approvals and site activation timelines.
Selected market
Spain
- Operating model
- Selected market with submission and delivery experience, run from the European delivery team.
- Site and investigator environment
- University hospitals with established device research activity.
- Regulatory pathway
- AEMPS authorisation with CEIm ethics committee approval.
- Feasibility focus
- Centralised ethics route and site-level contracting.
Selected market
Nordic markets
- Operating model
- Selected markets with submission experience in Denmark, run from the European delivery team.
- Site and investigator environment
- Centralised specialist centres with a strong registry and follow-up culture.
- Regulatory pathway
- National competent authority notification with regional ethics committee approval.
- Feasibility focus
- Registry linkage, small site numbers and high data completeness.
European teams work close to clinical sites and national regulatory pathways, coordinated through one quality and delivery model. Country-level operating models are stated as verified at the date of publication and reviewed before each programme starts.
Programme leadership
Senior experts accountable for your clinical and regulatory programme
Our physician leadership includes practising surgeons and former TÜV SÜD senior reviewers. They work alongside senior clinical operations, data and medical-writing leaders who remain involved from strategy through delivery and regulatory documentation.
Dr Mark Da Costa
Chief Operating Officer and Head of Cardiovascular
- Former TÜV SÜD Team Leader and Senior Clinical Reviewer
- Consultant Cardiac Surgeon
- Cardiovascular and structural heart
Mark leads Eclevar's cardiovascular clinical and regulatory strategy, combining 25 years of Consultant Cardiac Surgery experience with first-hand senior Notified Body leadership experience as a former TÜV SÜD Team Leader and Senior Clinical Reviewer.
- Cardiovascular and structural heart
- Class III clinical evidence
- Notified Body interactions
Dr Nikhil Khadabadi
Chief Medical Officer, Orthopaedics and Spine
- Former TÜV SÜD Senior Reviewer
- NHS Orthopaedic Surgeon
- Class III implantable devices
Nikhil leads Eclevar's orthopaedic, spine and surgical-robotics clinical strategy, combining current NHS orthopaedic practice with first-hand Notified Body review experience as a former TÜV SÜD Senior Reviewer specialising in Class III implantable devices. He has also worked as a Principal Investigator in robotic-surgery research.
- Orthopaedics, spine and surgical robotics
- Class III implantables
- CER and PMCF strategy
Charline Petitdemange
Project Delivery Lead, France and United Kingdom
- France and United Kingdom
Charline coordinates French and UK clinical programmes from mobilisation through close-out, across sponsor teams, clinical operations, data management, medical writing and external vendors.
- France and UK delivery
- Project mobilisation
- Risk and issue management
Sébastien Meier Piantanida
Chief Data Officer
- Clinical data and digital systems
Sébastien leads data strategy, data management and digital clinical systems. He owns the frameworks used to collect, standardise and analyse clinical data so that datasets remain traceable, interpretable and ready for scientific and regulatory use.
- Clinical data strategy
- EDC and eCOA governance
- Biometrics and reporting
Pierre-Marie Boutanquoi
Head of Medical Writing
- 10+ years of EU MDR clinical evidence
Pierre-Marie leads the medical-writing function with more than ten years of experience across EU MDR clinical evidence programmes. He specialises in Clinical Evaluation Reports, PMCF documentation, clinical investigation reports and responses to complex Notified Body deficiencies.
- Clinical Evaluation Reports
- PMCF plans and reports
- 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 programmes.
Study-specific EDC and eCOA, role-based workflows, monitoring signals, query management, data-quality review, approved imaging-related data and analysis-ready datasets that feed directly into clinical reporting.
Programme proof. Used in RegenLab's European chronic-wound programme, across both wound populations and all participating sites.
Watch the MILO Studio demonstration2 minutes, opens on YouTube
Publications and external evidence
Published work, client perspectives and industry collaboration
Published material and client accounts, rather than claims about ourselves.
Published whitepaper · BSI and Eclevar
EU MDR post-market clinical follow-up: gaining real-world evidence
A practical reading of the clinical evidence expectations under EU MDR, written with the Notified Body BSI and relevant to any high-risk device programme.
Read the BSI and Eclevar whitepaper
Client perspective · RegenLab
Running a European chronic-wound PMCF programme
Antoine Turzi, Chief Executive Officer of RegenLab, on how the programme was designed and delivered across two wound populations and 14 European sites.
Watch the RegenLab interview on YouTube
Industry collaboration · xShare and EUCROF
EHDS and Clinical Research Open Call results
The announcement of the Open Call winners by xShare and EUCROF, co-funded by the European Union, including the clinical-research use case submitted by Eclevar.
Read the announcement on xshare-project.euStart a discussion
Planning a clinical investigation, PMCF programme or EU MDR evidence strategy?
Share your device category, development stage, target countries and principal evidence question. Eclevar's clinical and regulatory team will identify the main clinical, operational, data and reporting workstreams for an initial discussion.
- 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
Tell us the device category, the development stage and the evidence question. The first call is with the people who would run the programme.
Discuss your programme- Response within one business day, subject to the published service standard.
- Explore client programmes