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Medical Device Regulation training

Medical Device Regulation training
flexible workload from 4 to 360h
valid certificate in your country

What will I learn?

Medical Device Regulation Training gives you a focused, practical overview of EU MDR 2017/745 for Class IIb wearable cardiac monitors. Learn how to align your quality management system with ISO 13485 and ISO 14971, build compliant technical documentation, manage software and cybersecurity, prepare clinical evaluation and PMCF, design PMS and vigilance systems, and get audit-ready with clear, actionable tools you can apply immediately.

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 workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.
Workload: between 4 and 360 hours

What our students say

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The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Very great course. Lots of valuable information.
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