ISO 14971 Course
Master ISO 14971 for medical devices and wearables. Learn to identify hazards, estimate and control risks, meet MDR and FDA requirements, and create a compliant risk management file that safeguards patients, facilitates regulatory approvals, and enhances device safety. This course equips you with essential skills for building and maintaining effective risk processes in medical technology.

4 to 360 hours of flexible workload
certificate valid in your country
What Will I Learn?
Gain practical, step-by-step guidance to develop a compliant risk management process for wearable heart rate and SpO2 monitors. Master defining intended use, identifying hazards from software, batteries, sensors and cybersecurity, estimating and prioritising risks, implementing and verifying controls, documenting residual risk, and maintaining a robust risk management file with effective postmarket surveillance.
Elevify Advantages
Develop Skills
- Apply ISO 14971 to swiftly build compliant risk files for medical wearables.
- Analyse device usage by clearly defining intended use, potential misuse, and user profiles.
- Identify hazards by mapping risks 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 surveillance.
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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