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ISO 14971 Course

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

What will I learn?

Gain step-by-step guidance on creating a compliant risk management process for wearable heart rate and SpO2 monitors under ISO 14971. Master defining intended use, spotting hazards in software, batteries, sensors, and cybersecurity, assessing and ranking risks, applying and checking controls, recording residual risks, and keeping a solid risk file with ongoing postmarket monitoring.

Elevify advantages

Develop skills

  • Apply ISO 14971 to quickly create compliant risk files for medical wearables.
  • Analyse device usage by defining intended use, potential misuse, and user profiles.
  • Identify key hazards from software, batteries, sensors, and cybersecurity threats.
  • Prioritise risks using straightforward matrices, severity ratings, and ALARP principles.
  • Implement controls and verify them through safety tests, usability checks, and postmarket data.

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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