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Root Cause Analysis (RCA) for Medical Devices Masterclass

"Root Cause Analysis (RCA) for Medical Devices Masterclass" teaches structured problem-solving approaches to identify and address product issues. Participants learn various RCA methods and their application to device reliability. In cybersecurity, RCA ensures that after a breach or vulnerability discovery, thorough analysis leads to permanent fixes and stronger security architectures for medical devices.

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, Instructor-Led
  • Online, Instructor-Led

Learning Objectives

  • Master various Root Cause Analysis (RCA) methodologies for medical devices.
  • Conduct thorough investigations of medical device failures and adverse events.
  • Identify the underlying causes of problems and implement effective corrective actions.
  • Develop skills in using RCA tools and techniques.
  • Comprehensive RCA for medical devices should include investigating cybersecurity incidents to prevent future occurrences.

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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