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. One operational chain from feasibility to post-market follow-up.
The strategic vision behind Eclevar MedTech. Sets the long-term direction, anchors the company's positioning as a specialist EU MDR CRO, and protects the operational standards.
Translates strategy into execution across all business functions, guaranteeing on-time milestones for sponsors[cite: 200, 210].
Ensures the financial discipline and contractual rigor that medical device sponsors and venture investors expect[cite: 219, 285].
The clinical engine of Eclevar MedTech. This is where studies are designed, sites are activated, and evidence is built[cite: 196, 210].
End-to-end ownership of each study lifecycle. Accountable for timelines and budget[cite: 210, 234].
In-house CRAs across France, Germany, Italy, and Spain under EU MDR and ISO 14155:2020[cite: 279, 283].
Investigator selection and ethics committee submission management for rapid activation[cite: 197, 268].
CER, CIP, and PMCF reports authored by experts with Notified Body experience[cite: 177, 229].
Where clinical evidence becomes regulatory-grade data via our proprietary MILO platform.
Database build and data validation. ISO 14155 and 21 CFR Part 11 compliant[cite: 192, 240].
Native EDC, eCRF, and eConsent engineered specifically for medical devices[cite: 250, 260].
Roadmap ownership integrating EU AI Act and MDCG guidance updates[cite: 27, 254].
The commercial and therapeutic interface structured around therapeutic expertise, regional reach, and global brand presence[cite: 182, 285].
The independent oversight layer and operational foundation for sustained growth[cite: 187, 219].
ISO 13485 QMS ownership and Notified Body inspection support[cite: 187, 192].
Real-time monitoring of EU MDR, FDA, and PMDA evolution[cite: 125, 273].
Targeted hiring of former Notified Body assessors and device experts[cite: 188, 219].
Infrastructure for multi-year, multi-million-euro development programs[cite: 214, 260].
