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Medical Device Risk Management Per ISO 14971 Essentials
"Medical Device Risk Management Per ISO 14971 Essentials" trains professionals on identifying, assessing, and mitigating risks throughout a device's lifecycle. Participants gain practical experience applying ISO standards. In cybersecurity, integrating risk management for software and hardware ensures that vulnerabilities are systematically addressed, protecting both patients and healthcare providers from cyber incidents.
Course Overview
None
Learning Objectives
- Understand the principles and requirements of ISO 14971 for medical device risk management.
- Identify, analyze, and evaluate risks associated with medical devices.
- Develop and implement risk control measures.
- Maintain risk management documentation throughout the device lifecycle.
- Effective risk management in medical devices includes identifying and mitigating cybersecurity risks to protect patient data and device functionality.
Framework Connections
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
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.