Length: 2 Days
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Medical Device Reliability Training by Tonex

Fundamentals of Medical Device Engineering for Industrial and Production Engineers & Technicians

This course focuses on the reliability of medical devices, addressing ISO 13485 and regulatory requirements, reliability testing, risk management (ISO 14971), and design for reliability. Participants will learn to ensure the safety and reliability of medical devices through comprehensive strategies and best practices.

Learning Objectives:

  • Understand and comply with ISO 13485 and other regulatory requirements.
  • Conduct effective reliability testing for medical devices.
  • Implement risk management strategies in accordance with ISO 14971.
  • Design medical devices with reliability as a core focus.

Audience:

  • Medical Device Engineers
  • Reliability Engineers
  • Quality Assurance Professionals
  • Regulatory Compliance Officers
  • Product Development Managers

Program Modules:

  1. ISO 13485 and Regulatory Requirements
    • Overview of ISO 13485 and Regulatory Frameworks
    • Compliance Strategies for Medical Device Reliability
    • Documentation and Reporting for Regulatory Compliance
    • Case Studies on ISO 13485 Implementation
    • Tools and Technologies for Compliance Management
    • Continuous Improvement in Regulatory Compliance
  2. Reliability Testing for Medical Devices
    • Fundamentals of Reliability Testing for Medical Devices
    • Planning and Conducting Reliability Tests
    • Analyzing Reliability Test Data
    • Case Studies on Reliability Testing Success
    • Tools and Technologies for Reliability Testing
    • Developing a Comprehensive Test Plan
  3. Risk Management (ISO 14971) for Medical Devices
    • Introduction to ISO 14971 and Risk Management
    • Techniques for Risk Identification and Analysis
    • Implementing Risk Mitigation Strategies
    • Case Studies on Risk Management in Medical Devices
    • Tools and Technologies for Risk Management
    • Continuous Improvement in Risk Management Practices
  4. Design for Reliability in Medical Devices
    • Principles of Designing for Reliability in Medical Devices
    • Techniques for Embedding Reliability into Design
    • Case Studies on Design for Reliability Success
    • Tools and Methods for Design Validation
    • Best Practices for Design Review and Improvement
    • Continuous Improvement in Design for Reliability

 

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