ISO 14971 Course
Gain mastery in ISO 14971 for medical devices and wearables. The course teaches hazard identification, risk assessment and control, compliance with MDR and FDA standards, and creation of a robust risk management file to safeguard patients, aid regulatory approvals, and boost device safety. It equips you with hands-on skills for effective risk handling in real-world scenarios.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This ISO 14971 course offers practical step-by-step guidance to develop 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 create compliant risk files for medical wearables.
- Analyse device usage by defining intended use, potential misuse, and user characteristics clearly.
- Identify key hazards linked to software, batteries, sensors, and cybersecurity effectively.
- Prioritise risks using straightforward matrices, severity ratings, and ALARP principles.
- Implement controls and verify them through safety tests, usability checks, 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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