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ISO 14971 Course

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

What will I learn?

This course provides step-by-step guidance to establish a compliant risk management process for wearable heart rate and SpO2 monitors. You will 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 ongoing postmarket monitoring.

Elevify advantages

Develop skills

  • Apply ISO 14971 to quickly create compliant risk files for medical wearables.
  • Analyse device usage by clearly defining intended use, potential misuse, and user profiles.
  • Identify key hazards linked to software, batteries, sensors, and cybersecurity.
  • Prioritise risks using straightforward matrices, severity ratings, and ALARP principles.
  • Implement and validate controls through testing safety, usability, 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 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
Really great course. Lots of valuable information.
WiltonCivil Firefighter

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