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Medical Device Regulation training

Medical Device Regulation training
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.
Workload: between 4 and 360 hours

What our students say

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EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Great course. Lots of valuable information.
WiltonCivil Firefighter

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