Bring the study to the patient. We design and run decentralized and hybrid clinical investigations for medical devices, combining remote data capture, ePROs and in-home visits with EU MDR and ISO 14155 rigour.
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
Leading device manufacturers choose Eclevar for clinical evidence and real world evidence. Read all client success stories.
Dr Mark Da Costa, COO and former TÜV SÜD reviewer, leads a team that designs decentralized studies so that remote and in-home data hold the same traceability and quality a Notified Body expects, with in-house CRAs overseeing every site.
Traditional site-only studies limit recruitment to patients near a hospital and burden them with travel. Decentralized and hybrid designs widen access, improve retention and capture data in real-world settings.
For devices this must be done carefully: remote data still needs source verification, device accountability, eConsent and endpoints that a Notified Body can rely on. That is exactly how we build them.
Each component is validated, traceable and EU MDR / ISO 14155 aligned.
Remote consent and electronic patient-reported outcomes.
Televisits, home nursing and connected devices.
Direct capture on the MILO EDC platform with full audit trail.
Eclevar deploys in-house Clinical Research Associates in the United Kingdom, Germany, France and Sweden, ensuring smooth study initiation, ethics-committee submissions (for example CPP in France) and high-quality clinical data collection.
Decentralized or hybrid design tuned to your device and endpoints.
ePRO, eConsent, televisits and device accountability.
Risk-based monitoring by in-house CRAs.
Recruit beyond the catchment of a single hospital.
Lower patient burden improves retention.
Data captured in the patient’s real environment.
Source verification and audit trail for remote data.
ISO 14155:2026 and EU MDR alignment throughout.
Quicker recruitment and fewer site bottlenecks.
Data quality means completeness, consistency and accuracy across all investigational sites.
Assessing data-source quality, completeness and consistency.
A robust protocol aligned with ISO 14155:2026 and GCP.
Site activation, in-house CRAs, high-quality data collection.
Rigorous statistical analysis of safety and performance.
Comprehensive reports for Notified Body and authorities.
RegenLab needed PMCF data to renew its CE marking without disrupting clinical workflows. Eclevar designed a targeted RWE-PMCF registry study on the MILO EDC platform capturing wound-healing trajectories and adverse-event tracking.
Multicentre study with retrospective and prospective record data from French university hospitals (CHU Valenciennes, Nantes, Brest), covering carotid and femoral locations up to 3 years post-op and meeting EU MDR requirements for CE certification.
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 clinical program.
Eclevar manages RegenLab's PMCF program on chronic wound devices: 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.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
A study where some or all activities happen away from a traditional site, using remote data capture, ePRO, eConsent and in-home visits.
Yes, when data integrity, source verification, device accountability and endpoints are handled to ISO 14155 and EU MDR standards.
A study that mixes on-site and remote elements, keeping site visits where they are clinically necessary and decentralizing the rest.
Validated systems, eConsent, direct capture on MILO EDC with a full audit trail and risk-based monitoring by in-house CRAs.
Those with remotely measurable endpoints or PROMs; we assess feasibility per device during design.
Talk to our team about a decentralized or hybrid design that widens recruitment while staying Notified Body ready.
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