Log in
Choose your language

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

I was just promoted to Intelligence Advisor for the Prison System, and the course from Elevify was crucial for me to be the chosen one.
EmersonPolice Investigator
The course was essential to meet the expectations of my boss and the company I work for.
SilviaNurse
Great course. Lots of valuable information.
WiltonCivil Firefighter

FAQs

Who is Elevify? How does it work?

Do the courses come with a certificate?

Are the courses free?

What is the course duration?

What are the courses like?

How do the courses work?

What is the duration of the courses?

What is the cost or price of the courses?

What is an online course and how does it work?

PDF Course