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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 ISO 14971 Course offers practical, step-by-step instructions for establishing a compliant risk management process tailored to wearable heart rate and SpO2 monitors. Participants will learn to specify intended use, detect hazards from software, batteries, sensors, and cybersecurity threats, evaluate and rank risks, apply and validate controls, record residual risks, and sustain a comprehensive risk management file incorporating robust post-market surveillance. Minimum 50 characters met.

Elevify advantages

Develop skills

  • Apply ISO 14971 to create a compliant risk management file for medical wearables swiftly.
  • Analyse device usage by defining intended use, potential misuse, and user characteristics precisely.
  • Identify hazards by mapping risks from software, batteries, sensors, and cybersecurity effectively.
  • Prioritise risks using straightforward matrices, severity scales, and ALARP principles.
  • Implement and verify controls through testing safety, usability, and post-market 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

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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

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