ISO 14971 Course
This course equips you to apply ISO 14971 effectively for medical wearables. You will learn to pinpoint hazards, evaluate and mitigate risks, align with MDR and FDA standards, and develop a robust risk management file that safeguards patients, aids regulatory approvals, and bolsters device safety through practical techniques and real-world examples.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Gain step-by-step guidance on creating a compliant risk management process for wearable heart rate and SpO2 monitors under ISO 14971. Master defining intended use, spotting hazards in software, batteries, sensors, and cybersecurity, assessing and ranking risks, applying and checking controls, recording residual risks, and keeping a solid risk 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 defining intended use, potential misuse, and user profiles.
- Identify key hazards from software, batteries, sensors, and cybersecurity threats.
- 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.What our students say
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