ISO 14971 (Medical Device Risk Management) Essentials from Tonex, Inc.

ISO 14971 (Medical Device Risk Management) Essentials

Online, Self-Paced

Master medical device risk management with "ISO 14971 (Medical Device Risk Management) Essentials." Learn how to identify, evaluate, and mitigate risks to ensure compliance with international safety standards.

Learning Objectives

Understand the principles of medical device risk management according to ISO 14971.
Analyze the risk management process, including risk analysis, evaluation, and control.
Evaluate the methods for hazard identification and risk estimation.
Identify the documentation requirements for risk management activities.
Discuss the application of ISO 14971 throughout the medical device lifecycle.

Framework Connections

Oversight and Governance

The materials within this course focus on the NICE Framework Task, Knowledge, and Skill statements identified within the indicated NICE Framework component(s):

Competency Areas

Work Roles

Feedback

If you would like to provide feedback on this course, please e-mail the NICCS team at NICCS@mail.cisa.dhs.gov. Please keep in mind that NICCS does not own this course or accept payment for course entry. If you have questions related to the details of this course, such as cost, prerequisites, how to register, etc., please contact the course training provider directly. You can find course training provider contact information by following the link that says “Visit course page for more information...” on this page.