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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

I was just promoted to Intelligence Advisor of the Prison System, and the course from Elevify was crucial for me to be chosen.
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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