Safety Risk Management for Medical Devices: Aligning with ISO 14971:2019 from Tonex, Inc.

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 safety risk management aligned with ISO 14971:2019.
Learn to implement risk control measures for medical devices.
Develop comprehensive safety risk management documentation.
Ensure compliance with updated ISO 14971 requirements.
Improve patient safety and device reliability.

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

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.