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ISO 14971 Course

ISO 14971 Course
from 4 to 360h flexible workload
certificate valid 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 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 get straight to the point and how I can switch chapters and skip content I don't need.
Mariana Ferres
Mariana FerresPhotography Student
I like the content and the way the videos are presented and transcribed, which speeds up the process!
Luciana Alvarenga
Luciana AlvarengaNail Design Student
The platform is fast and easy to use. The variety of content and the extra videos really help with learning.
Giulio Carlo
Giulio CarloPrompt Engineering Student

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