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ISO 14971 Course

ISO 14971 Course
flexible workload of 4 to 360h
valid certificate in your country

What will I learn?

The ISO 14971 Course gives you practical, step-by-step guidance to build a compliant risk management process for wearable heart rate and SpO2 monitors. Learn to define intended use, identify hazards from software, batteries, sensors, and cybersecurity, estimate and prioritize risks, implement and verify controls, document residual risk, and maintain an effective risk management file with strong postmarket surveillance.

Elevify advantages

Develop skills

  • Apply ISO 14971: build a compliant risk file for medical wearables fast.
  • Analyze device use: capture intended use, misuse, and user profiles clearly.
  • Identify hazards: map software, battery, and cybersecurity risks in practice.
  • Prioritize risks: design simple matrices, severity scales, and ALARP decisions.
  • Implement and verify controls: test safety, usability, and postmarket feedback.

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
Very great course. Lots of rich information.
WiltonCivil Firefighter

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