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Medical Device Regulation training

Medical Device Regulation training
4 to 360h 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 your QMS with ISO 13485 and ISO 14971, develop compliant technical files including GSPR and UDI, conduct clinical evaluations with CEP, CER, and PMCF, establish PMS and vigilance systems, manage software via IEC 62304 and cybersecurity risks, and prepare for audits with actionable strategies.

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.
Workload: between 4 and 360 hours

What our students are saying

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Giulio CarloDigital Marketing Student
I like how the lessons are straight to the point and how I can change chapters and skip content I don't need.
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Mariana FerresPhotography Student
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