ISO 14971 Course
Gain expertise in ISO 14971 for medical devices and wearables. Master identifying hazards, assessing and controlling risks to satisfy MDR and FDA standards, and creating a compliant risk management file that safeguards patients, aids regulatory approvals, and boosts device safety. With practical steps for wearables like heart rate and SpO2 monitors, you'll handle everything from hazard mapping to postmarket surveillance effectively.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This course provides step-by-step guidance to establish a compliant risk management process for wearable heart rate and SpO2 monitors. You will 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 ongoing postmarket monitoring.
Elevify advantages
Develop skills
- Apply ISO 14971 to quickly create compliant risk files for medical wearables.
- Analyse device usage by clearly defining intended use, potential misuse, and user profiles.
- Identify key hazards linked to software, batteries, sensors, and cybersecurity.
- Prioritise risks using straightforward matrices, severity ratings, and ALARP principles.
- Implement and validate 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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