A specialist neuromodulation CRO for complex device programmes in Europe: spinal cord stimulation (SCS), deep brain stimulation (DBS), vagus nerve stimulation (VNS) and active neuro-implants. Shaped from inside the Notified Bodies, our clinical strategy is built the way regulators expect to see it, from the very first version of the protocol.
Platinum Award 2026
First 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
Dr Mark DaCosta is a surgeon and former Notified Body assessor at TÜV SÜD, with more than 400 devices certified in Europe. As COO, he brings a direct Notified Body reading to every neuromodulation programme, from SCS, DBS and VNS systems to complex active neuro-implants and their PMCF programmes, right across the European Union. He ensures that assessment criteria translate into approvals and robust labelling claims, from the very first version of the protocol.
Clinicians and former Notified Body assessors, close to delivery. Every profile is reachable directly on LinkedIn.
Former Notified Body assessor for Class III implants. PMCF and CER methodology.
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Clinical evaluation and CER, from protocol through to Notified Body deficiency responses.
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30 years of biometrics. Architect of the MILO EDC platform, compliant with 21 CFR Part 11.
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Oversees the ISO 13485:2016 certified QMS. Inspection-ready data from day one.
LinkedInFrom SCS to active implants, manufacturers choose Eclevar as their specialist neuromodulation CRO. Discover our client testimonials.
Full clinical strategy and execution for an SCS programme targeting refractory chronic pain. Eclevar designed the study architecture with a responder analysis (pain reduction ≥ 50%), validated VAS/NRS scales, a long-term follow-up structure and a dossier strategy for the EU MDR Annex IX certification route.
Emergency rebuild of the EDC and the complete PMCF data governance for an active implantable Class III neurostimulator, following inspection findings. Validation of a new platform, run in parallel with CAPA and remediation workstreams, and delivery of inspection-ready data for the Notified Body.
Eclevar MedTech is a premium CRO specialised in neuromodulation clinical trials, dedicated to clients with premium, innovative, first-in-class and best-in-class devices. Every neuromodulation programme we take on receives dedicated senior attention, from protocol design through to PMCFER submission. We apply this same specialist model to implants through our orthopaedics and spine CRO practice.
Our leadership team includes a former Notified Body assessor. Clinical programmes are designed exactly to regulatory expectations, before the first version of the submission.
Breaking down indication-specific composite endpoints, validated neurological rating scales (UPDRS, VAS/NRS, seizure diaries), variable standards and imaging core lab integration.
A key differentiator for Eclevar MedTech. We structure investigator-initiated studies (IIS) that turn off-label practice into ethical, auditable and regulator-acceptable evidence.
Long-term follow-up design for Class III neuro-implants. Drafting of the PMCF Plan, PMCF Evaluation Report (PMCFER) and registry integration aligned with MDCG 2020-7.
Neuromodulation-specific eCRF architecture, EDC validation to 21 CFR Part 11 and ISO 14155:2020, immutable audit trails and an inspection simulation mode built into our MILO EDC platform.
In-house CRAs across the seven main EU countries. Local regulatory and ethics expertise in France, Germany, United Kingdom, Italy, Spain, Sweden and Denmark, with consistent global standards.
Many high-risk neuromodulation procedures are performed off-label before formal regulatory approval is obtained. Eclevar MedTech designs investigator-initiated studies (IIS) that generate data usable for post-market follow-up analyses and regulatory submissions.
Identify the clinical questions in your Notified Body submission that remain unanswered by the current evidence.
Structure the study with endpoints, visit schedules and an eCRF architecture perfectly aligned with Annex XIV.
Eclevar MedTech prepares the entire ethics submission meeting each country's specific requirements, across all participating sites.
All data is captured in MILO EDC with pre-populated Annex XIV traceability columns. Clean data feeds the PMCFER from day one.
The PMCFER is updated with the evidence from the IIS. Your Notified Body submission reflects the expanded indication with inspection-grade data.
From first-in-class neurostimulation systems to the most complex evidence-generation programmes, Eclevar MedTech supports global neuromodulation device manufacturers at every stage of the regulatory lifecycle.
Full clinical strategy and execution for an SCS programme targeting patients with refractory chronic pain. Eclevar MedTech designed the study architecture with a responder analysis, validated VAS/NRS scales, a long-term follow-up structure and a dossier strategy for the EU MDR Annex IX certification route.
Evidence-generation programme for a portfolio of neurostimulation electrodes and leads. Eclevar MedTech structured a PMCF study combining prospective registry data collection with a systematic literature review, generating high-quality regional datasets for the EU MDR recertification of several variants simultaneously.
An IIS programme designed to turn established off-label DBS practice into regulator-acceptable evidence for indication expansion. Eclevar MedTech designed the IIS protocol with indication-specific endpoints, an imaging sub-study and a MILO EDC data architecture traceable to the residual risks in the manufacturer's PMCF Plan.
Emergency EDC remediation and complete rebuild of PMCF data governance for an active implantable Class III neurostimulator, following inspection findings. Validation of a new platform, run in parallel with CAPA and remediation workstreams, and delivery of inspection-ready data for the Notified Body.
Where our consultants, including our former Notified Body expert, are speaking, and what we are building. Come and find us, or book a call.
Dr Mark DaCosta, COO and former Notified Body expert, speaks on the EU MDR and the introduction of new neuromodulation devices.
clientcare@eclevar.comOur award-winning platform reads a neuromodulation protocol and returns three costed scenarios (fast, base, conservative) along with a recruitment forecast.
Explore the platform ↗The Eclevar team, including our former Notified Body expert, on what neurostimulation trials must satisfy to pass Notified Body review.
clientcare@eclevar.comWhitepapers, client testimonials and publications produced by our teams and our partners (BSI, TÜV SÜD, RegenLab).
Written with the Notified Body BSI: a practical reading of clinical evidence expectations under EU MDR 2017/745, useful for any high-risk device programme, neuromodulation 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 coming soon.
Dr Nikhil KhadabadiCMO · Eclevar MedTech
Look for four things: a direct Notified Body reading within the team, a methodology specific to neuromodulation (validated scales such as the UPDRS, pain VAS/NRS, seizure diaries, imaging core lab integration), in-house CRAs in your target countries, and verifiable references such as a delivered SCS or DBS programme. Eclevar combines all four pillars, with a former Notified Body assessor in its leadership team.
Neuromodulation programmes under EU MDR call for specific skills: breaking down indication-specific composite endpoints, validated neurological rating scales, management of stimulation-related adverse events and imaging core lab integration. Eclevar builds this into the protocol from the first version, with a direct Notified Body reading provided by a former assessor on the leadership team.
Yes. Eclevar designs the full clinical strategy and execution of neurostimulation programmes, with a breakdown of indication-specific endpoints, a long-term follow-up structure and a dossier strategy compliant with Annex IX of the EU MDR.
An investigator-initiated study (IIS) turns established off-label clinical practice, for example DBS in new indications, into ethical, auditable and regulator-acceptable evidence. Eclevar structures the protocol, the ethics submissions and the MILO EDC data architecture so that the evidence feeds directly into your PMCF Evaluation Report.
In-house CRAs across the seven main EU countries: France, Germany, United Kingdom, Italy, Spain, Sweden and Denmark, plus a Latin American presence in Brazil and Colombia, as well as a Japan corridor for PMDA alignment.
Yes. For an implantable Class III neurostimulator, Eclevar rebuilds the complete PMCF data governance after inspection findings and delivers inspection-ready data for the Notified Body, with no major finding.
Our neuromodulation franchise draws on the full range of Eclevar MedTech's regulatory and clinical services.
Regulatory strategy, technical review and Annex XIV alignment from the design of the dossier.
Learn more ↗PMCF Plan, PMCFER and registry integration for your Class III neuro-implants.
Learn more ↗Drafting of a robust CER that stands up to Notified Body review.
Learn more ↗The same specialist CRO model applied to orthopaedic and spinal implants.
Learn more ↗Our award-winning platform: 21 CFR Part 11 validated EDC and recruitment forecasting.
Explore the platform ↗A team including a former Notified Body assessor at the service of your programmes.
Meet the team ↗Whether you are developing an SCS, DBS or VNS system, an active neuro-implant, planning an indication expansion or remediating a PMCF data programme before your next Notified Body surveillance visit, Eclevar MedTech delivers a coherent, regulator-ready clinical strategy.
