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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?

This ISO 14971 course offers practical step-by-step guidance to develop a compliant risk management process for wearable heart rate and SpO2 monitors. You will learn to define intended use, spot hazards from software, batteries, sensors, and cybersecurity threats, assess and rank risks, apply and check controls, record remaining risks, and keep a solid risk management file with robust postmarket monitoring.

Elevify advantages

Develop skills

  • Apply ISO 14971 principles to quickly create compliant risk files for medical wearables.
  • Analyse device usage by defining intended use, potential misuse, and user characteristics clearly.
  • Identify key hazards linked to software, batteries, sensors, and cybersecurity effectively.
  • 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

Your classes are perfect. I got the one-year package and finally have the chance to follow several topics I'm interested in without having to switch platforms... I appreciate everything you do, I've already recommended you to others...
Giulio Carlo
Giulio CarloDigital Marketing Student
I like how the lessons are straight to the point and how I can switch chapters and skip content I don't need.
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Mariana FerresPhotography Student
I like the content and the way the videos are presented and transcribed, which speeds up the process!
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Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the supplementary videos really help with learning.
Giulio Carlo
Giulio CarloPrompt Engineering Student

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