Medical Device Regulation training
Gain expertise in EU MDR for medical devices, focusing on wearable cardiac monitors. Master ISO 13485 quality systems, ISO 14971 risk management, clinical evaluations, PMS, cybersecurity, UDI, and technical files to launch compliant devices and pass Notified Body audits.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This training provides a practical overview of EU MDR 2017/745 tailored to Class IIb wearable cardiac monitors. You will learn to align your QMS with ISO 13485 and ISO 14971, develop compliant technical files, handle software and cybersecurity, conduct clinical evaluations and PMCF, establish PMS and vigilance, and prepare for audits using actionable tools.
Elevify advantages
Develop skills
- Build MDR-compliant QMS: align ISO 13485, define PRRC role, and prepare for audits.
- Create MDR technical documentation: map GSPR, implement UDI, register in EUDAMED, and gather Class IIb evidence.
- Develop clinical evaluations: prepare CEP and CER, analyse performance data, and plan PMCF for wearables.
- Apply ISO 14971: conduct risk analyses, implement controls, and integrate PMS feedback.
- Manage software and cybersecurity: follow IEC 62304, apply threat controls, and oversee 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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