FMEA, FTA and Risk Assessment for Medical Devices | Training Bootcamp 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 FMEA and FTA methodologies for medical devices.
Identify and assess risks in medical device systems.
Learn to integrate FTA and FMEA into safety analysis.
Develop effective risk mitigation strategies.
Enhance compliance with medical device safety regulations.

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.