A European CRO for complex cardiovascular device programs. Designed from the inside of Notified Bodies, our clinical strategy is built the way regulators expect to see it from the very first protocol version.
Eclevar Medtech is a premium CRO, seeking clients with premium, novel, first-in-class and best-in-class devices. Every cardiovascular program we accept receives dedicated senior attention and conviction from protocol design to PMCFER submission.
Our leadership team includes former Notified Body reviewers. Clinical programs are designed exactly according to regulatory expectations before the first submission version.
VARC-3 composite endpoint decomposition, transcatheter heart valve-specific biometric architecture, hemodynamic variable standards, and core lab integration.
A key Eclevar Medtech differentiator. We structure Investigator-Initiated Studies that convert off-label clinical practice into ethical, auditable, and regulator-acceptable evidence.
Long-term follow-up design for Class III cardiovascular implants. PMCF Plan authoring, PMCF Evaluation Report, and registry integration aligned with MDCG 2020-7.
VARC-3 eCRF architecture, EDC validation to 21 CFR Part 11 and ISO 14155:2020, immutable audit trails, and inspection simulation mode built into our MILO EDC platform.
In-house CRAs across top seven EU countries. Local regulatory and ethics expertise in France, Germany, UK, Italy, Spain, Sweden, and Denmark apply consistent global standards.
Many high-risk cardiovascular procedures are performed off-label before formal regulatory approval is secured. Eclevar Medtech designs Investigator-Initiated Studies (IIS) that generate data suitable for future post-market follow-ups analyses and regulatory submissions.
Identify which clinical questions in your existing Notified Body submission remain unanswered by current evidence.
Structure the study with endpoints, visit schedules, and eCRF architecture perfectly aligned to Annex XIV.
Eclevar Medtech prepares the full ethical dossier addressing country-specific requirements across all participating sites.
All data is captured in the MILO EDC with Annex XIV traceability columns pre-populated. Clean, error-proof data feeds directly into the PMCFER from day one.
PMCFER is updated with IIS-derived evidence. Your Notified Body submission reflects the expanded indication with inspection-grade data.
"Off-label use in TAVI for bicuspid aortic valve, mitral regurgitation bridge procedures, and complex anatomy cases generate rich clinical data. Without structured capture, this evidence disappears. With Eclevar Medtech IIS architecture, it becomes the foundation of your next PMCF Evaluation Report."
Every Eclevar Medtech cardiovascular program is led by senior practitioners with comprehensive structural heart and other cardiovascular devices regulatory experience. Eclevar Medtech also involves its Key Opinion Leaders advisory Boards, providing insights and validation.
Former TÜV SÜD reviewer. As the head of the Cardiovascular practice at Eclevar Medtech, Mark is on the frontline of all TAVI and other structural heart assignments, and all complex cardiovascular guidewires PMCF programs across the European Union. He provides direct Notified Body insight for every clinical strategy to ensure endpoints translate into regulatory approvals and powerful labels.
Founder of Eclevar Medtech and former Notified Body reviewer. He developed the cardiovascular vertical at Eclevar Medtech, the proprietary MILO EDC platform, and the Japan PMDA corridor. Chems leads the global strategic direction of the firm while sharing his extensive experience across client assignments.
Thirty years of clinical data experience acquired in worldclass Pharma and Medtech organisations. Sébastien provides deep expertise in cardiovascular EDC architecture, including VARC-3 endpoint decomposition, MACE derivation logic, and imaging core lab integration. He is the principal architect of the MILO EDC platform.
Commercial lead for all cardiovascular clients. He serves as the primary contact for manufacturers developing complex Class III devices such as TAVI systems or planning indication expansion under EU MDR. He acts as the conference lead organiser for the firm and coordinates clients’ priorities.
Senior project strategy and clinical operations lead for cardiovascular programs with previous experience with world Medtech leaders and major CROs. She manages site qualification, investigator training, and ISO 14155:2020 compliance oversight across all European territories.
Operational specialist for complex cardiovascular studies. She manages Ethics Committee submissions across multiple European jurisdictions and oversees PMCF data collection for structural heart programs.
Former TÜV SÜD specialist. As a senior regulatory and clinical lead, he provides direct Notified Body reviewer experience. He possesses deep expertise in EU MDR requirements for Class III implantable devices.
From first-in-class TAVI systems to complex guidewire evidence generation programs, Eclevar Medtech supports global cardiovascular device manufacturers at every stage of the regulatory lifecycle.
Full clinical strategy and execution for a TAVI program targeting high-risk and non-surgical patient populations. Eclevar Medtech designed the study architecture with VARC-3 composite endpoint decomposition, five-year follow-up structure, and regulatory file strategy for EU MDR Annex IX certification pathway.
Evidence generation program for a broad portfolio of coronary and peripheral access guidewires. Eclevar Medtech structured a PMCF study combining prospective registry data collection with systematic literature surveillance, generating high-quality regional evidence datasets for EU MDR re-certification across multiple device variants simultaneously.
An IIS program designed to convert established off-label TAVI practice in bicuspid aortic valve anatomy into regulatory-acceptable evidence for indication expansion. Eclevar Medtech designed the IIS protocol with BAV-specific endpoints, CT imaging sub-study, and MILO EDC data architecture traceable to the manufacturer's PMCF Plan residual risks.
Emergency EDC remediation and full PMCF data governance rebuild for a Class III cardiac rhythm management device following ANSM inspection findings. Validated new platform, executed parallel CAPA and PROM licensing remediation workstreams, and delivered Notified Body inspection-ready data in 9 months from engagement.
Whether you are developing a TAVI system or any other structural heart device, planning an indication expansion, or remediating a PMCF data program before your next Notified Body surveillance visit, Eclevar Medtech provides a consistent, regulator-ready clinical strategy.
