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ISO 14971 Course

ISO 14971 Course
4 to 360h flexible workload
certificate valid in your country

What will I learn?

This course provides step-by-step guidance on establishing a compliant risk management process for wearable heart rate and SpO2 monitors under ISO 14971. Participants will learn to define intended use, identify hazards from software, batteries, sensors, and cybersecurity threats, assess and prioritize risks, apply and verify controls, document residual risks, and sustain a robust risk management file incorporating postmarket surveillance.

Elevify advantages

Develop skills

  • Apply ISO 14971 principles to rapidly develop compliant risk management files for medical wearables.
  • Analyze device usage by clearly defining intended use, potential misuse, and user characteristics.
  • Identify key hazards related to software, batteries, sensors, and cybersecurity vulnerabilities.
  • Prioritize risks using straightforward matrices, severity ratings, and ALARP evaluation methods.
  • Implement and verify risk controls, including safety testing, usability assessments, and postmarket monitoring.

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.
Workload: between 4 and 360 hours

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