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ISO 14971 Course

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

What Will I Learn?

Gain practical, step-by-step guidance to develop a compliant risk management process for wearable heart rate and SpO2 monitors. Master defining intended use, identifying hazards from software, batteries, sensors and cybersecurity, estimating and prioritising risks, implementing and verifying controls, documenting residual risk, and maintaining a robust risk management file with effective postmarket surveillance.

Elevify Advantages

Develop Skills

  • Apply ISO 14971 to swiftly build compliant risk files for medical wearables.
  • Analyse device usage by clearly defining intended use, potential misuse, and user profiles.
  • Identify hazards by mapping risks from software, batteries, sensors, and cybersecurity.
  • Prioritise risks using straightforward matrices, severity scales, and ALARP principles.
  • Implement and verify controls through testing safety, usability, and postmarket surveillance.

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 lessons are perfect. I purchased the one-year package and finally have the opportunity to follow various topics of my interest without needing to change platforms... I thank you for everything you do, I've already recommended you to other people...
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.
Mariana Ferres
Mariana FerresPhotography Student
I like the content and the way videos are presented and transcribed, which speeds up the process!
Luciana Alvarenga
Luciana AlvarengaNail Design Student
The platform is fast, simple to use. The diversity of content and complementary videos really help with learning.
André Felipe
André FelipePrompt Engineering Student

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