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 develop a compliant risk management file that safeguards patients, aids regulatory approvals, and bolsters device safety. This course equips you with essential tools to handle real-world challenges in medical device risk management effectively.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This ISO 14971 course offers practical, step-by-step advice to create a compliant risk management process for wearable heart rate and SpO2 monitors. You will learn to 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 robust postmarket monitoring.
Elevify advantages
Develop skills
- Apply ISO 14971 principles to quickly build a compliant risk file 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 ratings, and ALARP principles.
- Implement and verify controls through testing 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.What our students say
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