ISO 14971 Course
Master ISO 14971 for medical devices and wearables. Learn to identify hazards, estimate and control risk, meet MDR/FDA expectations, and build a compliant risk management file that protects patients, supports approvals, and strengthens device safety.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
The ISO 14971 Course gives you practical, step-by-step guidance to build a compliant risk management process for wearable heart rate and SpO2 monitors. Learn to define intended use, identify hazards from software, batteries, sensors, and cybersecurity, estimate and prioritize risks, implement and verify controls, document residual risk, and maintain an effective risk management file with strong postmarket surveillance.
Elevify advantages
Develop skills
- Apply ISO 14971: build a compliant risk file for medical wearables fast.
- Analyze device use: capture intended use, misuse, and user profiles clearly.
- Identify hazards: map software, battery, and cybersecurity risks in practice.
- Prioritize risks: design simple matrices, severity scales, and ALARP decisions.
- Implement and verify controls: test safety, usability, and postmarket feedback.
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 workloadWhat our students say
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