Eclevar MedTech builds and remediates ISO 13485:2016 Quality Management Systems for medical device manufacturers, audit-ready from Day 1, aligned to EU MDR Article 10 and structured to survive Notified Body surveillance visits without findings.
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
Device leaders rely on Eclevar to build, remediate and maintain their QMS. Read all client success stories.
Our QMS practice is led by Jimmy Andrew Hayek, Head of Quality & Compliance, an ISO 13485:2016 lead with EU MDR and 21 CFR Part 11 validation expertise. The team also includes former Notified Body assessors, so your quality system is built the way a surveillance auditor reads it.
"Quality in clinical research is not a final checkpoint. It is the structural foundation of every protocol we write, every site we monitor, and every dataset we lock for submission."
A quality system aligned to ISO 13485 is the base. EU MDR Article 10 adds obligations that a generic QMS misses. We build them in.
The designated PRRC function required under EU MDR Article 15.
Formal PMS processes feeding the technical documentation.
72-hour reporting, FSCA notifications and EUDAMED registration.
UDI procedures and EUDAMED registration.
Clinical evaluation linked to design controls as a lifecycle process.
Version management and controlled technical documentation.
A fast, structured review of where your QMS stands today.
A formal gap analysis report with a prioritised remediation roadmap.
QMS build or remediation: SOP library, Quality Manual and training.
A clause-by-clause internal audit with CAPA initiation.
Notified Body Stage 1 and Stage 2 audit, with Eclevar alongside you.
Certificate maintenance and surveillance management.
An SOP library written from scratch for the EU MDR, not adapted from ISO 9001.
The team includes former Notified Body assessors who know what surveillance looks for.
QMS obligations are automatically addressed when we also manage your PMCF and CER.
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 and quality expectations under EU MDR 2017/745.
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. »
Full scope definition and Quality Manual, an SOP library of 40 to 80 procedures, design controls and DHF structure, ISO 14971 risk management, CAPA, complaint handling and vigilance, and PMS integration. Typical implementation from scratch is 3 to 5 months.
A CAPA for Notified Body findings typically takes 6 to 12 weeks, covering gap analysis against Article 10, root cause analysis, SOP remediation with an audit trail, technical documentation alignment and re-audit readiness verification.
Yes. QMS maintenance provides an outsourced Quality Manager function with annual internal audits, management review facilitation, CAPA trend analysis, complaint and vigilance management and surveillance visit preparation.
Yes. The QMS covers the Person Responsible for Regulatory Compliance (Article 15), post-market surveillance, vigilance on EU MDR timelines (Articles 87 to 89, including 72-hour reporting), UDI and EUDAMED registration, clinical evaluation as a lifecycle process and technical documentation control.
Our SOP library is written from scratch for the EU MDR, not adapted from ISO 9001; the team includes former Notified Body assessors; and QMS obligations are automatically addressed when we also manage your PMCF and CER.
A 30-minute structured review of your quality system, followed by a formal gap analysis report and a clear remediation roadmap.
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