A unified structure across five integrated functions, designed to deploy specialized clinical, data and regulatory teams on demand for the most complex EU MDR and global medical device programs. No silos. No handoff friction.
A single accountable chain of command, from strategic vision down to the specialist teams that run every EU MDR and global program.
Specialized clinical, data and regulatory teams deployed on demand for complex EU MDR and global device programs, in one operational chain from feasibility to post-market follow-up.
The clinical engine: project management, in-house clinical monitoring, site feasibility & start-up, medical writing (CER, CIP, PMCF) and health economics.
Where evidence becomes regulatory-grade data: clinical data management under ISO 14155 and 21 CFR Part 11, the MILO EDC platform and product management.
The therapeutic interface: therapeutic-area owners across cardiovascular, orthopedics, neuro and wound care, plus regional development and global marketing.
The independent oversight layer: ISO 13485 QMS ownership, Notified Body inspection support and real-time EU MDR, FDA and PMDA regulatory intelligence.
The operational foundation: targeted recruitment of former Notified Body assessors, structured onboarding, and finance built for multi-year device programs.
Sets the long-term direction and anchors Eclevar's positioning as a specialist EU MDR CRO, protecting operational standards.
Translates strategy into execution across every function, guaranteeing on-time milestones. Led by Dr Mark Da Costa, former Notified Body reviewer.
Ensures the financial discipline and contractual rigour that medical device sponsors and investors expect.
Five functions under one accountable command, so your program moves from feasibility to post-market follow-up without handoff friction.
Clinical operations are never subcontracted. In-house CRAs across France, Germany, Italy and Spain work under EU MDR and ISO 14155:2026.
Book a call and we will map which functions your EU MDR or global device program needs, and how we deploy them on demand.
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