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ISO 14971: Risk Management for Medical Devices Essentials

Understand medical device risk management with "ISO 14971: Risk Management for Medical Devices Essentials." Learn how to apply risk management processes to ensure compliance and patient safety.

Course Overview

Overall Proficiency Level
2 - Intermediate
Course Catalog Number
T101
Course Prerequisites

None

Training Purpose
Functional Development
Management Development
Specific Audience
All
Delivery Method
Online, Self-Paced
  • Online, Self-Paced

Learning Objectives

  • Understand the requirements of ISO 14971.
  • Apply risk management principles to medical devices.
  • Perform hazard identification and risk assessment.
  • Understand the risk control measures.
  • Understand the monitoring and post-market surveillance requirements.

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):

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.

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