Length: 2 Days
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Medical Device and Equipment Failures Training by Tonex

FMEA, FTA and Risk Assessment for Medical Devices

This course focuses on applying Root Cause Analysis (RCA) to medical device and equipment failures. Participants will learn how to use RCA to enhance the reliability and safety of medical devices and comply with regulatory requirements.

Learning Objectives:

  • Apply RCA to identify root causes of medical device failures.
  • Conduct post-market surveillance RCA.
  • Comply with FDA reporting requirements.
  • Enhance equipment maintenance and reliability practices.

Audience:
Biomedical engineers, quality managers, regulatory compliance officers, and anyone involved in medical device manufacturing and maintenance.

Program Modules:

Module 1: RCA in Medical Device Manufacturing

  • Overview of medical device manufacturing processes
  • Applying RCA to identify root causes of manufacturing issues
  • Developing and implementing corrective actions
  • Case studies on RCA in medical device manufacturing
  • Practical exercises
  • Hands-on workshops

Module 2: Post-Market Surveillance RCA

  • Principles of post-market surveillance
  • Applying RCA to identify and address post-market issues
  • Developing and implementing corrective actions
  • Case studies on post-market surveillance RCA
  • Practical exercises
  • Hands-on workshops

Module 3: FDA Reporting Requirements

  • Overview of FDA regulations for medical devices
  • Integrating RCA with FDA reporting requirements
  • Identifying and addressing compliance issues
  • Case studies on FDA reporting and RCA
  • Practical exercises
  • Hands-on workshops

Module 4: Equipment Maintenance and Reliability

  • Principles of equipment maintenance and reliability
  • Applying RCA to identify maintenance issues
  • Developing and implementing maintenance strategies
  • Case studies on equipment maintenance and reliability
  • Practical exercises
  • Hands-on workshops

 

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