Medical Device Regulation training
Gain expertise in EU MDR 2017/745 for Class IIb wearable cardiac monitors. Master ISO 13485 quality systems, ISO 14971 risk management, clinical evaluations, PMS, vigilance, cybersecurity, UDI, and technical documentation to launch compliant devices and pass Notified Body audits confidently.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This training provides a practical overview of EU MDR 2017/745 focused on 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, set up PMS and vigilance, and prepare for audits with immediately applicable tools.
Elevify advantages
Develop skills
- Build MDR-ready QMS by aligning ISO 13485, defining PRRC role, and preparing for audits.
- Create compliant MDR technical files with GSPR mapping, UDI, EUDAMED, and Class IIb evidence.
- Develop clinical evaluations including CEP, CER, performance data, and PMCF for wearable devices.
- Apply ISO 14971 for risk analysis, control measures, and integrating PMS feedback.
- Manage software and cybersecurity using IEC 62304, threat controls, and cloud supplier oversight.
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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