ISO 14971 Course
Gain mastery in ISO 14971 for medical devices and wearables. Learn to pinpoint hazards, evaluate and manage risks, satisfy MDR and FDA rules, and develop a compliant risk management file that safeguards patients, aids regulatory approvals, and boosts device safety. This course equips you with hands-on skills to handle real-world challenges in medical tech.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This ISO 14971 course offers practical steps to create a compliant risk management system for wearable heart rate and SpO2 monitors. You will define intended use, spot hazards from software, batteries, sensors, and cyber threats, assess and rank risks, apply and check controls, record remaining risks, and keep a solid risk file with ongoing market monitoring.
Elevify advantages
Develop skills
- Apply ISO 14971 principles to quickly build 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 threats.
- 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 workloadWhat our students say
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