ISO 14971 Course
Master 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. This protects patients, aids regulatory approvals, and boosts device safety through strong postmarket surveillance.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Gain practical steps to create a compliant risk management process for wearable heart rate and SpO2 monitors. 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 monitoring.
Elevify advantages
Develop skills
- Apply ISO 14971 to quickly build compliant risk files for medical wearables.
- Analyse device usage to clearly define 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 with testing for 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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