Where device
manufacturers
build regulatory
certainty.
Premier European CRO specialising in EU MDR regulatory affairs, PMCF clinical investigations, clinical data management and digital clinical studies.
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 validation, data interoperability, and patient-centred study design.
Co-funded by the European Union xShare EHR Xchange Format - Open Call for Clinical Research - Best CRO Innovation in EU.
End-to-end clinical execution
for complex 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.
Orthopedics & 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 programs 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 14155:2020 protocol design, Ethics Committee approvals, and conduct rigorous site monitoring.
Data Management & Regulatory
21 CFR Part 11 compliant data capture via our proprietary MILO EDC platform. Combined with expert biostatistics, systematic CER authoring, and Notified Body-ready clinical evaluation.
Experts from Both Sides of the Table
Prof. Mark DaCosta
Direct experience in high-level Notified Body Q&A cycles for Class III medical devices.
Dr. Nikhil Khadabadi
Former TÜV SÜD Senior Reviewer with Class III devices focus. Specialises in implantable device clinical evidence processes.
Dr. Yumiko Kida
Former Notified Body Assessor (Intertek and SGS) with over two decades of dual-perspective expertise.
Nancy Boodhun
Senior lead for site qualification and ISO 14155:2020 compliance oversight.
Sébastien Meier
30 years in Biometrics. Architect of the MILO EDC platform and data governance.
MILO EDC: The inspection-
native data platform.
Generic clinical study platforms are not built for medical devices. When fields lack Annex XIV mapping or audit trails fail on field modifications, you fail Notified Body review.
MILO was built to make these gaps structurally impossible. Inspection readiness is not a pre-audit sprint — it is the default state encoded into every record.
AI eCRF Generator
Reads your PMCF Protocol and proposes a complete EDC dictionary with Annex XIV mapping pre-populated.
Smart Query Engine
AI-assisted cross-visit anomaly detection. Reduces manual data review by 60%.
Inspection Dashboard
Real-time TMF completeness scoring. Know your Notified Body inspection readiness score instantly.
Part 11 Native
Immutable audit trail from Day 1. No configuration required. Notified Body compliant out of the box.
for Lifecycle Outcomes
Evidence you can
build a strategy on.
A structured engagement model that moves fast without cutting regulatory corners. From signed agreement to Notified Body submission.
Clinical Strategy
Assess PMCF obligations, Annex XIV gaps, and define the fastest compliant pathway.
Protocol & DMP
Endpoint-to-CER mapping and Data Management Plan authored prior to EDC build.
Ethics & Submissions
Full EC dossier preparation and national CA submission. EUDAMED registration.
EDC & Activation
MILO EDC validated, sites qualified, investigators trained, and monitoring activated.
PMCF Delivery
Database lock, statistical analysis, and final report ready for Notified Body review.
Our Global
Infrastructure
Direct operational presence and strategic corridors across major medical device markets worldwide.
Your pending Notified Body submission
should be the last one
with findings.
Whether you are designing a first PMCF program, 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.
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