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 obligations, and structured to survive Notified Body surveillance visits without findings.
EU MDR requires a Quality Management System for all Class IIa, IIb, and III device manufacturers under Annex IX certification.
Serious incident reporting window under EU MDR vigilance. Your QMS must have exact workflows to meet this obligation.
Major Notified Body surveillance audit findings across Eclevar-supported QMS clients since 2022.
Typical implementation time for a full ISO 13485:2016 Quality Management System from scratch.
Whether you are building your first Quality Management System, remediating an existing system before a Notified Body audit, or aligning a certified system to the new EU MDR obligations, Eclevar Medtech has a defined service model for your stage.
For startups, early-stage manufacturers, and companies preparing for a first Notified Body engagement under EU MDR. We design and implement a full QMS calibrated to your device class.
For manufacturers with existing ISO 13485 certification who have received Notified Body audit findings or whose QMS was implemented under MDD. We execute a targeted remediation CAPA.
For manufacturers who have achieved certification but lack in-house Quality Manager capacity. Eclevar Medtech operates as your outsourced Quality team, ensuring continuous audit-readiness.
With extensive experience navigating complex Medtech quality frameworks, Jimmy leads the compliance infrastructure at Eclevar Medtech. He oversees the ISO 13485:2016 certified Quality Management System, ensuring that every clinical investigation, PMCF program, and dataset perfectly aligns with EU MDR 2017/745 and Notified Body expectations.
Holding ISO 13485:2016 certification is not sufficient for EU MDR compliance. Article 10 introduces specific Quality Management System obligations that extend beyond the standard.
MDR Article 15 requires a designated PRRC. This function must be formally documented with responsibilities, authority, and independence to escalate concerns.
The PMS system must be a formal process for proactive and reactive data collection, signal detection thresholds, and feedback loops into clinical evaluation.
Must include the Art. 87-89 decision tree: serious incident classification, 72-hour reporting for immediate risks, FSCA notifications, and EUDAMED registration.
The QMS must include UDI assignment, labeling, and EUDAMED registration procedures covering the full lifecycle, including UDI changes.
Clinical evaluation is a lifecycle process embedded in the QMS with defined update triggers linked to design controls and PMS signals.
A procedure covering exact structure, review triggers, version control, and the essential linkage between CER, PMS, and risk management.
A structured delivery model that moves fast without exposing the manufacturer to audit risk. Most first-time implementations reach NB Stage 2 certification in 14-16 weeks.
Free 30-minute call to assess the current QMS status against ISO 13485:2016 and EU MDR Article 10 requirements.
Written gap analysis covering all eight sections of ISO 13485, including a remediation roadmap with timeline and resource estimates.
SOP library authored, Quality Manual written, processes documented, and training records established covering all obligations.
A comprehensive internal audit performed against ISO 13485 clause-by-clause. Non-conformities are identified and CAPAs initiated.
Eclevar Medtech team presence for audit preparation and support. Real-time query response targeting zero Major NCRs.
ISO certificate issuance. Annual surveillance visits managed and continuous regulatory change monitoring ensured.
Most manufacturers discover ISO gaps during the audit. A gap identified internally requires a CAPA and a week of work. Found during Stage 2, it means a Major NCR, follow-up visit, and 3-6 months delay.
Our free call provides a structured review of your documentation against ISO 13485:2016 and Article 10.
Our SOP library is written from the ground up for EU MDR, not adapted from generic ISO 9001. Every procedure references the specific MDR Article it satisfies.
Our team includes former Notified Body assessors who understand which SOP formulations generate queries and what survives unannounced surveillance visits.
When we manage your PMCF study or CER, your QMS obligations (like Clause 7.4 supplier control and data integrity) are automatically addressed.
Book a free Gap Assessment call. We will map your current QMS status, identify critical gaps, and provide a clear remediation roadmap.
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