We do not just deliver documents. As a medical device CRO in Europe, we build strategic partnerships that turn EU MDR complexity into a competitive advantage for Class II and Class III device manufacturers: Notified Body deficiencies closed, PMCF delivered, clinical strategy that holds up in review.
Platinum Award 2026
Top prize in the xShare × European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Milo Health and presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Every engagement below is a verified client result - not a case study template. These are the deficiencies closed, the studies delivered, and the strategies that held up under Notified Body scrutiny.
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."
For its implantable neuromodulation device, the manufacturer needed a partner who understands how European Notified Body reviewers think. Eclevar anticipated the deficiencies a reviewer would raise, structured the responses, and built the PMCF and clinical strategy behind the submission. This is the same capability we apply when a deficiency letter has already landed.
Shofu Inc. partnered with Eclevar to streamline their Clinical Evaluation Reports and equivalence strategy across their dental portfolios. The objective: a defensible, Notified Body-ready clinical evidence package that would survive rigorous technical file review under EU MDR 2017/745 - delivered by a team that has reviewed files from the other side of the table.
Meril Life Sciences engaged Eclevar to design and deliver a multi-centre reimbursement clinical study in the United Kingdom for their TAVI (Transcatheter Aortic Valve Implantation) device portfolio. The study was structured to satisfy both UK NICE evidence requirements and post-Brexit MDR-equivalent expectations - combining Eclevar's cardiovascular clinical expertise with a site network across leading UK cardiology centres. In parallel, Eclevar supports Meril's PMCF survey strategy across their Class III cardiovascular and orthopaedic portfolios.
Dr. Axel Schulz, orthopaedic surgeon based in Germany, shares his experience working with Eclevar's Milo Studio platform for clinical trial planning and documentation. His feedback captures what matters most to clinical investigators: speed, clarity, and regulatory defensibility from day one - without weeks of back-and-forth between sponsor and CRO.
"The platform removes the friction from clinical planning. What used to take weeks of back-and-forth is now a structured roadmap in minutes."
Terumo engaged Eclevar to navigate EU MDR requirements for their vascular device portfolio - bridging the gap between Japanese regulatory logic and the clinical evidence expectations of European Notified Bodies. The engagement covered clinical evaluation strategy, PMCF architecture, and structured deficiency response methodology built around Eclevar's knowledge of how Notified Body reviewers assess Class III vascular submissions.
Mölnlycke engaged Eclevar to build clinical evidence strategy and post-market clinical follow-up programmes across their advanced wound care portfolio under EU MDR. The work covered launching two distinct multicentre PMCF study programmes in France, one for diabetic foot ulcer (DFU) and one for venous leg ulcer (VLU), together with gap analysis against MDCG guidance, PMCF study design, and the clinical evaluation reports needed to sustain CE marking through ongoing review cycles - delivered with the rigour of a team that has assessed wound care submissions from inside a Notified Body.
Beyond our featured stories, Eclevar supports a growing network of medical device manufacturers navigating EU MDR clinical evidence requirements.
Ongoing PMCF programme management for autologous PRP systems. Eclevar designs, monitors and reports studies across multiple European investigational sites in full compliance with ISO 14155:2026.
MDR transition and legacy evidence gap bridging across multiple device risk classes. Eclevar mapped the clinical evidence gaps in Vygon's existing technical files against EU MDR Annex XIV requirements and built a prioritised remediation roadmap.
Eclevar ran five observational PMCF studies in France for the Vygon group (Perouse Medical) covering implantable Class III vascular devices, built on real-world data to sustain CE marking through Notified Body review. Every submission cleared review with zero deficiencies raised.
Clinical strategy and compliance support for advanced medical devices across multiple European markets. Eclevar provides ongoing clinical evidence advisory integrated within Coloplast's regulatory affairs workflows.
Randomised crossover trial of a single-use compact micro-hole intermittent catheter, enrolling 72 female IC users across 10 sites in Denmark, the UK and France (continence & urology, 2023).
Cardiac surgeon and former senior reviewer at a Notified Body (TUV SUD).
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Leads clinical strategy across orthopaedic and spine device programmes.
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CERs, PMCF reports and submission documents built to Notified Body expectations.
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Data management, biostatistics and the Milo platform behind our forecasts.
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Pilote la réalisation des investigations cliniques et études PMCF en Europe. Qualification des sites, monitoring, TMF, ISO 14155:2026.
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Your first contact for scoping calls, partnerships and sponsor relationships.
LinkedInVerified client outcomes include a Notified Body review with zero Major Non Conformance Reports for Asahi Intecc, the resolution of Notified Body expectations for Nihon Kohden's Class IIa EEG, PMCF programmes for RegenLab's chronic diabetic foot ulcer devices, and a TAVI reimbursement multi centre study in the UK for Meril Life Sciences.
Yes. Our senior team includes a former Notified Body reviewer (TUV SUD). We structure deficiency responses, run colour coded gap evaluations and build the clinical strategy and PMCF evidence needed to close findings.
Cardiovascular and structural heart, orthopaedics and spine, dental and restorative technologies, EEG and neuro monitoring, renal, and advanced wound care, for Class IIa to Class III devices.
Yes. We support Japanese manufacturers such as Nihon Kohden, Asahi Intecc, Shofu and Terumo on EU MDR market access, and US manufacturers such as Gentell bridging FDA logic to EU MDR expectations.
Book a free scoping call. We review your device, regulatory status and clinical evidence needs, then propose a costed plan. Write to clientcare@eclevar.com.
Tell us about your device. We will show you how teams like Nihon Kohden and Meril solve EU MDR with Eclevar.
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