Medical Device Regulation training
Master EU MDR 2017/745 for Class IIb wearable cardiac monitors. Gain practical skills in ISO 13485 quality management, ISO 14971 risk analysis, clinical evaluations with PMCF, PMS and vigilance systems, software cybersecurity per IEC 62304, technical documentation including UDI and EUDAMED, plus audit readiness to launch compliant devices confidently.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Get a practical rundown on EU MDR 2017/745 focused on Class IIb wearable cardiac monitors. Learn to sync your QMS with ISO 13485 and ISO 14971, craft solid technical docs, handle software and cyber threats, prep clinical evals and PMCF, set up PMS and vigilance, and gear up for audits with tools you can use right away.
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 are saying
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