ISO 14971 Course
Gain mastery in ISO 14971 for medical devices and wearables. Identify hazards, assess and manage risks, align with 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 risks effectively in medical tech.

flexible workload from 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 to quickly build compliant risk files for medical wearables.
- Analyse device usage by clearly defining intended use, misuse, and user profiles.
- Identify hazards by mapping risks from software, batteries, and cybersecurity.
- Prioritise risks using simple matrices, severity scales, and ALARP principles.
- Implement and verify controls through testing safety, usability, and postmarket data.
Suggested summary
Before starting, you can change the chapters and 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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