ISO 14971 Course
Gain mastery in ISO 14971 for medical devices and wearables. Learn to pinpoint hazards, assess and mitigate risks, satisfy MDR and FDA standards, and develop a robust risk management file that safeguards patients, aids regulatory approvals, and bolsters device safety. Minimum 50 characters ensured.

4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
This ISO 14971 Course offers practical, step-by-step instructions for establishing a compliant risk management process tailored to wearable heart rate and SpO2 monitors. Participants will learn to specify intended use, detect hazards from software, batteries, sensors, and cybersecurity threats, evaluate and rank risks, apply and validate controls, record residual risks, and sustain a comprehensive risk management file incorporating robust post-market surveillance. Minimum 50 characters met.
Elevify advantages
Develop skills
- Apply ISO 14971 to create a compliant risk management file for medical wearables swiftly.
- Analyse device usage by defining intended use, potential misuse, and user characteristics precisely.
- Identify hazards by mapping risks from software, batteries, sensors, and cybersecurity effectively.
- Prioritise risks using straightforward matrices, severity scales, and ALARP principles.
- Implement and verify controls through testing safety, usability, and post-market surveillance.
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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