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Medical Device Regulation training

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

What our students are saying

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EmersonPolice Investigator
The course was essential to meet my boss's and the company's expectations.
SilviaNurse
Really great course. Lots of valuable information.
WiltonCivil Firefighter

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