ISO 14971 Course
Gain mastery in ISO 14971 for medical devices and wearables. Learn to pinpoint hazards, evaluate 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 training equips you to handle real-world challenges in medical tech risk processes effectively.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This ISO 14971 course offers hands-on steps to create a solid 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 strong risk file with ongoing market monitoring.
Elevify advantages
Develop skills
- Apply ISO 14971 principles to quickly build compliant risk files for wearable medical devices.
- Analyse device usage by clearly defining intended use, potential misuse, and user characteristics.
- Identify key hazards linked to software, batteries, sensors, and cybersecurity threats.
- Prioritise risks using straightforward matrices, severity ratings, and ALARP principles.
- Put controls in place and verify them through safety tests, usability checks, 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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