A specialist cardiovascular CRO for complex device programs in Europe: TAVI, structural heart, guidewires and perivascular. 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.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
From TAVI to guidewires, manufacturers choose Eclevar as their CRO specialist in cardiology. Read all client success stories.
Dr Mark DaCosta is a cardiac surgeon and former TÜV SÜD Notified Body reviewer who has certified more than 400 cardiovascular devices in Europe. As COO and Head of the cardiovascular practice, he is on the frontline of every TAVI and structural heart assignment and every complex guidewire PMCF program across the European Union. He brings direct Notified Body insight to each clinical strategy, so endpoints translate into approvals and powerful labels from the very first protocol version.
Eclevar MedTech is a premium CRO specialised in cardiovascular clinical trials, 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. We apply the same specialist model to implants through our orthopedic and spine CRO practice.
Our leadership team includes a former Notified Body reviewer. 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 up 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 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.
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, a five year follow up structure, and a regulatory file strategy for the 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, a 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 a new platform, executed parallel CAPA and PROM licensing remediation workstreams, and delivered Notified Body inspection ready data in 9 months from engagement.
Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, relevant to any high risk device programme, cardiovascular devices included.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
A Notified Body perspective on the designation, evidence generation and conformity assessment of breakthrough devices under the EU MDR. Joint publication to come.
Dr Nikhil KhadabadiCMO · Eclevar MedTechWhere our consultants, including our former Notified Body expert, are presenting and what we are building. Come and find us, or book a call.
The Eclevar team, including our former Notified Body expert, on what cardiovascular trials need to satisfy Notified Body review.
clientcare@eclevar.com
Dr Mark DaCosta, COO and former Notified Body expert, joins the CSI Frankfurt speaker panel on EU MDR and the introduction of new devices.
clientcare@eclevar.com
Our award winning platform reads a cardiovascular protocol and returns three costed scenarios (swift, base, conservative) plus a recruitment forecast.
Explore the platform ↗Look for four things: direct Notified Body insight on the team, cardiovascular specific methodology (VARC-3 endpoints, core lab integration, THV biometric architecture), in house CRAs in your target countries, and verifiable references such as a delivered TAVI program. Eclevar combines all four, with a former Notified Body reviewer leading the cardiovascular practice.
Cardiovascular programmes under EU MDR demand specific competence: VARC-3 composite endpoint decomposition, transcatheter heart valve biometric architecture, hemodynamic variable standards and core lab integration. Eclevar builds this into the protocol from the first version, with direct Notified Body insight from a former reviewer on the leadership team.
Yes. Eclevar delivered the full clinical strategy and execution for a TAVI programme targeting high risk and non surgical populations, with VARC-3 endpoint decomposition, a five year follow up structure and an EU MDR Annex IX file strategy, completed with zero major Notified Body findings.
An Investigator Initiated Study converts established off label clinical practice, for example TAVI in bicuspid aortic valve anatomy, into ethical, auditable and regulator acceptable evidence. Eclevar structures the protocol, ethics dossiers and MILO EDC data architecture so the evidence feeds directly into your PMCF Evaluation Report.
In house CRAs across the top seven EU countries: France, Germany, the UK, Italy, Spain, Sweden and Denmark, plus a LATAM presence in Brazil and Colombia and a Japan corridor for PMDA alignment.
Yes. For a Class III cardiac rhythm management device, Eclevar rebuilt the full PMCF data governance after ANSM inspection findings and delivered Notified Body inspection ready data in nine months, with zero major findings.
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.
clientcare@eclevar.com