Length: 2 Days
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Medical Device Risk Management Workshop with ISO 14971 Compliance Training by Tonex

FMEA, FTA and Risk Assessment for Medical Devices

The Medical Device Risk Management Workshop with ISO 14971 Compliance by Tonex is an in-depth training program designed to equip professionals in the medical device industry with the knowledge and skills required to manage risks effectively. This comprehensive workshop provides a detailed understanding of the ISO 14971 standard, which is crucial for ensuring the safety and effectiveness of medical devices.

Participants will learn best practices for risk management, including the identification, evaluation, and control of risks throughout the product lifecycle. Through a combination of lectures, interactive discussions, and practical exercises, attendees will gain valuable insights into regulatory requirements and how to implement a robust risk management process in their organizations.

Learning Objectives

  • Understand the principles and requirements of ISO 14971 for medical device risk management.
  • Identify and assess potential risks associated with medical devices.
  • Develop and implement risk control measures to mitigate identified risks.
  • Conduct risk management activities throughout the medical device lifecycle.
  • Ensure compliance with regulatory standards and improve overall device safety.
  • Communicate risk management strategies and findings effectively within the organization.

Audience

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

Program Modules

Module 1: Introduction to ISO 14971 and Risk Management

  • Overview of ISO 14971 standard
  • Importance of risk management in medical devices
  • Key terms and definitions
  • Regulatory context and global standards
  • Risk management framework and process
  • Role of risk management in product lifecycle

Module 2: Risk Analysis and Evaluation

  • Hazard identification techniques
  • Risk estimation methodologies
  • Severity and probability assessment
  • Risk evaluation criteria
  • Tools for risk analysis (e.g., FMEA, FTA)
  • Documenting risk analysis results

Module 3: Risk Control and Mitigation

  • Risk control strategies
  • Implementing risk control measures
  • Verification of risk controls
  • Risk-benefit analysis
  • Residual risk management
  • Documentation and communication of risk controls

Module 4: Risk Management in Product Development

  • Integrating risk management in design and development
  • Design controls and risk management
  • Human factors and usability engineering
  • Software risk management
  • Change management and risk re-evaluation
  • Case studies and practical exercises

Module 5: Post-market Risk Management

  • Post-market surveillance requirements
  • Monitoring and reporting adverse events
  • Risk management for product recalls
  • Periodic risk review and updates
  • Regulatory reporting obligations
  • Lessons learned from post-market data

Module 6: Compliance and Continuous Improvement

  • Ensuring compliance with ISO 14971
  • Internal audits and assessments
  • Training and competency development
  • Risk management file and documentation
  • Continuous improvement in risk management processes
  • Best practices and industry trends

This structured and comprehensive workshop aims to empower professionals with the necessary tools and knowledge to ensure that their medical devices meet the highest safety and compliance standards, ultimately enhancing patient safety and regulatory adherence.

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