Length: 2 Days
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Risk Management (ISO 14971) for Medical Devices Training by Tonex

This course provides comprehensive training on ISO 14971, the international standard for risk management of medical devices. Participants will learn how to apply risk management principles to ensure the safety and effectiveness of medical devices throughout their lifecycle.

Learning Objectives:

  • Understand the principles and processes of risk management in medical devices.
  • Learn to identify, assess, and control risks associated with medical devices.
  • Gain skills to implement a risk management process compliant with ISO 14971.
  • Understand the integration of risk management into the quality management system.
  • Develop documentation and reporting skills for risk management activities.
  • Learn to perform risk analysis and evaluations effectively.

Audience:

  • Risk Managers
  • Quality Assurance Professionals
  • Regulatory Affairs Specialists
  • Medical Device Engineers
  • Compliance Officers
  • Product Development Teams

Program Modules:

  1. Introduction to ISO 14971
    • Overview of ISO 14971
    • Importance of risk management in medical devices
    • Key concepts and terminology
    • Scope and applicability of the standard
    • Benefits of effective risk management
    • Regulatory context and requirements
  2. Risk Management Process Overview
    • Risk management framework
    • Risk management plan development
    • Risk management team and responsibilities
    • Integration with QMS
    • Continuous improvement in risk management
    • Documentation and record-keeping
  3. Risk Analysis
    • Hazard identification
    • Risk analysis techniques
    • Severity and probability assessment
    • Risk estimation methods
    • Use of fault tree analysis (FTA) and failure mode and effects analysis (FMEA)
    • Tools for risk analysis
  4. Risk Evaluation and Control
    • Risk evaluation criteria
    • Risk acceptability and risk-benefit analysis
    • Risk control measures and hierarchy of controls
    • Verification of risk control measures
    • Residual risk assessment
    • Monitoring and reviewing risk controls
  5. Post-Production Risk Management
    • Post-market surveillance and feedback
    • Incident reporting and analysis
    • Change management and risk re-evaluation
    • Communication with regulatory bodies
    • Adverse event reporting requirements
    • Vigilance system integration
  6. Documentation and Reporting
    • Risk management file requirements
    • Risk management report creation
    • Communication of risk management activities
    • Regulatory submission preparation
    • Documentation for audits and inspections
    • Best practices for effective documentation

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