ISO 14971 Course
Gain mastery in ISO 14971 risk management for medical devices and wearables. The course covers hazard identification, risk estimation and control, alignment with MDR and FDA requirements, and creation of a compliant risk management file. This ensures patient safety, facilitates regulatory approvals, and enhances overall device security through practical, actionable strategies.

4 to 360h flexible workload
certificate valid in your country
What will I learn?
This course provides step-by-step guidance on establishing a compliant risk management process for wearable heart rate and SpO2 monitors under ISO 14971. Participants will learn to define intended use, identify hazards from software, batteries, sensors, and cybersecurity threats, assess and prioritize risks, apply and verify controls, document residual risks, and sustain a robust risk management file incorporating postmarket surveillance.
Elevify advantages
Develop skills
- Apply ISO 14971 principles to rapidly develop compliant risk management files for medical wearables.
- Analyze device usage by clearly defining intended use, potential misuse, and user characteristics.
- Identify key hazards related to software, batteries, sensors, and cybersecurity vulnerabilities.
- Prioritize risks using straightforward matrices, severity ratings, and ALARP evaluation methods.
- Implement and verify risk controls, including safety testing, usability assessments, and postmarket monitoring.
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 are saying
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