Medical Device Regulation training
Master EU MDR 2017/745 for Class IIb wearable cardiac monitors. Gain practical skills in aligning ISO 13485 quality systems, ISO 14971 risk management, technical documentation, clinical evaluations, PMS, vigilance, software and cybersecurity compliance, ensuring audit readiness and market success under Notified Body review.

4 to 360 hours of flexible workload
certificate valid in your country
What Will I Learn?
This training provides a practical overview of EU MDR 2017/745 tailored for Class IIb wearable cardiac monitors. You will learn to align quality management with ISO 13485 and ISO 14971, develop compliant technical files, handle software and cybersecurity per IEC 62304, conduct clinical evaluations and PMCF, establish PMS and vigilance systems, and prepare effectively for audits using actionable tools.
Elevify Advantages
Develop Skills
- Build MDR-ready QMS: align ISO 13485, PRRC role, and audit preparation.
- Create MDR technical files: GSPR mapping, UDI, EUDAMED, and Class IIb evidence.
- Develop clinical evaluation: CEP, CER, performance data, and PMCF for wearables.
- Apply ISO 14971: run risk analyses, define controls, and close the PMS feedback loop.
- Manage software and cybersecurity: IEC 62304, threat controls, and cloud suppliers.
Suggested Summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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