ISO 14971 Course
Gain mastery in ISO 14971 for medical devices and wearables. Discover how to pinpoint hazards, evaluate and manage risks, satisfy MDR and FDA standards, and create a compliant risk management file that safeguards patients, aids regulatory approvals, and bolsters device safety. Perfect for professionals aiming to streamline risk processes efficiently.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This course offers practical, step-by-step guidance to establish a compliant risk management process for wearable heart rate and SpO2 monitors. You'll learn to define intended use, spot hazards from software, batteries, sensors, and cybersecurity threats, assess and rank risks, apply and validate controls, record residual risks, and keep a solid risk management file with robust postmarket surveillance.
Elevify advantages
Develop skills
- Apply ISO 14971 principles to quickly build compliant risk files for medical wearables.
- Analyse device usage by clearly defining intended use, potential misuse, and user profiles.
- Identify key hazards, including those from software, batteries, sensors, and cybersecurity.
- Prioritise risks using straightforward matrices, severity scales, and ALARP principles.
- Implement and verify 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.What our students say
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