Compliance is built by the people who write your protocols, CERs and PMCF plans. Eclevar trains and upskills medical device teams in good clinical practice under ISO 14155:2026, clinical evaluation and post-market clinical follow-up under EU MDR, led by trainers who include former Notified Body reviewers.
Consultant-led · Ex-Notified Body
Your team learns from the specialists who run real EU MDR programs on the MILO Studio platform that won the Platinum Award at the xShare & EUCROF 2026 Open Call, then applies it to your own devices.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders across cardiovascular, orthopedics, wound care and more choose Eclevar. Read all client success stories.
It is consultant-led upskilling that gives a medical device team the competencies to run clinical investigations, write defensible Clinical Evaluation Reports and plan post-market clinical follow-up the way EU MDR and Notified Bodies expect.
For medical devices, good clinical practice is defined by ISO 14155:2026 and EU MDR 2017/745, not the pharma ICH-GCP framework. Training covers sponsor, investigator and monitor responsibilities, informed consent, risk management, adverse event and device deficiency reporting, and the data-integrity discipline that a medical device clinical investigation must hold from protocol version 1.
The program is modular. Teams choose the units they need: GCP under ISO 14155:2026, building the Clinical Evaluation Report under MDCG 2020-6, PMCF planning and execution under MDCG 2020-7, clinical data management and EDC selection, ISO 13485 quality systems, and multi-country clinical investigation submissions. Every module is adaptable to the manufacturer's therapeutic area and its own devices.
Training feeds directly into the work: a team that understands the clinical evaluation report and post-market clinical follow-up writes and defends the evidence that keeps a CE certificate valid.
Eclevar's model brings the regulatory perspective inside the training room, eliminating the gap between what manufacturers submit and what assessors expect. Dr Mark Da Costa, COO and former TÜV SÜD reviewer, and Dr Nikhil Khadabadi, CMO for orthopedics and spine and also a former TÜV SÜD senior reviewer, lead sessions that teach teams to design clinical evidence exactly the way Notified Bodies expect to read it, from the first protocol version.
Who trains your team, and on which standard, decides whether your evidence survives inspection. The gap between an off-the-shelf pharma GCP course and device-native training is structural.
Seven modular units, taken together or singly, each adaptable to your therapeutic area and delivered online or as an on-site day with a hands-on advisory clinic on your real files.
Good clinical practice for devices: sponsor, investigator and monitor duties, consent, risk-based GCP and what changed from ISO 14155:2020, tied to a real clinical investigation workflow.
Choosing the clinical evidence pathway for a CE mark: equivalence, clinical investigation, the state of the art and how strategy maps to EU MDR regulatory strategy.
Literature methodology, clinical data appraisal, benefit-risk and structure of the clinical evaluation report under MDCG 2020-6, written the way Notified Bodies read it.
Writing the PMCF plan and report under MDCG 2020-7, choosing between surveys, registries and studies, and feeding results into post-market clinical follow-up.
How to specify eCRFs, data management plans and validation, and how to select an EDC and data management platform built for EU MDR.
Embedding clinical work in an ISO 13485 quality system and preparing multi-country clinical investigation submissions.
The same in-house team that trains your people also runs EU MDR programs end to end, so what you learn is exactly how the work is delivered, with nothing lost between a course and a submission.
Pre and post-market trials under ISO 14155, from feasibility and site selection and study initiation through multi-country ethics submissions and clinical monitoring.
The clinical evaluation report under MDCG 2020-6, PMCF Plans and SSCP, written by clinicians and reviewed by former Notified Body assessors.
100% in-house clinical data management and EDC: eCRF design, DMP and DVP, powered by MILO Studio, natively built for EU MDR.
Structured post-market clinical follow-up meeting MDCG 2020-7 Level 4 criteria, with validated questionnaires and MILO Studio capture.
National registry integration (NJR, EUDAMED) for long-term real world evidence and PMCF follow-up of implantable devices.
Regulatory affairs and clinical strategy for CE mark pathways and equivalence, backed by a quality management system certified to ISO 13485.
A device manufacturer preparing a first EU MDR clinical investigation needed its clinical, regulatory and quality staff aligned on ISO 14155:2026 and on the evidence a Notified Body would expect. Eclevar delivered an on-site day: the morning covered GCP for devices, the clinical route and conformity strategy, and how to build a defensible clinical evaluation report.
The afternoon became a hands-on advisory clinic. Trainers worked through the manufacturer's own protocol, CER outline and PMCF plan, mapping each to EU MDR requirements and to the data management decisions that follow, so the team left with corrections applied to real documents rather than generic notes.
Outcome: a clinical, regulatory and quality team speaking one language, with certificates aligned to ISO 14155:2026 and EU MDR, and a protocol and CER already moving in the right direction.
Trainers include former Notified Body reviewers from TÜV SÜD. We teach what fails inspection and how to avoid it.
Clinical ops, writing and data management under one roof. What you learn is exactly how the work is delivered.
Proprietary EDC built natively for EU MDR, with Annex XIV mapping and AI eCRF generation, used in the training.
Paris, London, Tokyo and Pune. On-site training across the EU, the UK and Japan corridors, not remote-only.
Platinum Award winner, EUCROF 2026, ranked first for clinical innovation and data strategy.
ISO 13485 certified, with a delivery record of no major Notified Body non-conformities on the programs we run.
A team of employed specialists, not subcontractors, delivers online and on-site training with consistent quality and one accountable point of contact across the EU, the UK and Japan corridors.
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, ideal supporting material for teams training on CER and PMCF.
Eclevar manages RegenLab's PMCF program 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. »
ISO 14155 training teaches good clinical practice (GCP) for medical device clinical investigations. It covers the ethical and scientific requirements of ISO 14155:2026, the responsibilities of sponsors, investigators and monitors, informed consent, risk management, adverse event and device deficiency reporting, and how device GCP differs from the pharma ICH-GCP framework used for drugs.
Clinical evaluation training shows teams how to build a defensible clinical evaluation report under EU MDR 2017/745 and MDCG 2020-6: literature search methodology, appraisal and weighting of clinical data, equivalence, the state of the art, benefit-risk determination and how to structure the CER the way a Notified Body expects to read it.
PMCF training covers post-market clinical follow-up under EU MDR Annex XIV Part B and MDCG 2020-7: how to write a PMCF plan and report, choose between surveys, registries and studies, define Level 1 to Level 4 activities, and feed the results back into the CER to keep a CE certificate valid across its lifecycle.
Training highlights the practical differences a device team must act on: reinforced risk-based GCP, clarified sponsor and monitor responsibilities, alignment with EU MDR clinical requirements, and tightened expectations on data integrity, safety reporting and clinical investigation documentation. The focus is on what teams must change in their own SOPs and files.
Both. Eclevar delivers focused online modules and full on-site training days across Europe. On-site sessions combine taught modules with a hands-on advisory clinic on the manufacturer's own devices, protocols and CERs, so teams leave with decisions applied to their real files, not generic slides.
Yes. Participants receive a certificate of completion aligned to ISO 14155:2026 and EU MDR 2017/745, signed by the lead trainer. Certificates support GCP training records for sponsor, investigator and monitor roles that Notified Bodies and auditors expect to see in a trial master file and quality system.
Device clinical work runs under ISO 14155 and EU MDR, not ICH-GCP, and must handle operator-dependent variables, device learning curves, implant follow-up and endpoints mapped to the General Safety and Performance Requirements. A specialist medical device CRO whose trainers include former Notified Body reviewers teaches teams to build evidence the way assessors expect to read it.
Talk to our specialists about your devices, your team and a modular training program delivered online or on-site, aligned to ISO 14155:2026 and EU MDR.
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