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ISO 14971 Course

ISO 14971 Course
from 4 to 360h flexible workload
valid certificate in your country

What will I learn?

This ISO 14971 course offers practical steps to create a compliant risk management system for wearable heart rate and SpO2 monitors. You will define intended use, spot hazards from software, batteries, sensors, and cyber threats, assess and rank risks, apply and check controls, record remaining risks, and keep a solid risk file with ongoing market monitoring.

Elevify advantages

Develop skills

  • Apply ISO 14971 to quickly build compliant risk files for medical wearables.
  • Analyse device usage to clearly define intended use, misuse, and user profiles.
  • Identify hazards by mapping risks from software, batteries, and cybersecurity.
  • Prioritise risks using simple matrices, severity scales, and ALARP principles.
  • Implement and verify controls with tests for safety, usability, and postmarket data.

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

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 where I work.
SilviaNurse
Very great course. Lots of rich information.
WiltonCivil Firefighter

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