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Mastering ISO 14971; A Step-by-Step Guide to Medical Device Risk Management

Mastering ISO 14971; A Step-by-Step Guide to Medical Device Risk Management

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Mastering ISO 14971: A Step-by-Step Guide to Medical Device Risk Management



Course Overview

This comprehensive course provides a step-by-step guide to medical device risk management, utilizing the principles outlined in ISO 14971. Participants will gain a thorough understanding of the risk management process, from identifying and analyzing risks to implementing and monitoring risk mitigation strategies.



Course Objectives

  • Understand the principles and requirements of ISO 14971
  • Identify and analyze risks associated with medical devices
  • Develop and implement effective risk mitigation strategies
  • Monitor and review risk management activities
  • Apply risk management principles to real-world scenarios


Course Outline

Module 1: Introduction to ISO 14971

  • Overview of ISO 14971
  • History and development of the standard
  • Key principles and requirements
  • Relationship to other standards and regulations

Module 2: Risk Management Principles

  • Definition of risk and risk management
  • Risk management process
  • Risk assessment and analysis
  • Risk mitigation and control
  • Risk review and monitoring

Module 3: Identifying and Analyzing Risks

  • Risk identification techniques
  • Hazard analysis and risk assessment
  • Risk estimation and risk evaluation
  • Prioritizing risks
  • Documenting risk analysis results

Module 4: Implementing Risk Mitigation Strategies

  • Risk mitigation options
  • Design and development controls
  • Production and process controls
  • Post-market surveillance and vigilance
  • Corrective and preventive actions

Module 5: Monitoring and Reviewing Risk Management Activities

  • Risk management review process
  • Risk monitoring and reporting
  • Post-market risk assessment
  • Periodic safety update reports
  • Management review and continuous improvement

Module 6: Applying Risk Management Principles to Real-World Scenarios

  • Case studies and group discussions
  • Applying risk management principles to various medical devices
  • Risk management challenges and solutions
  • Best practices and lessons learned

Module 7: ISO 14971 and Regulatory Compliance

  • Relationship between ISO 14971 and regulatory requirements
  • Compliance with FDA, EU, and other regulatory agencies
  • Preparing for audits and inspections
  • Maintaining compliance and staying up-to-date

Module 8: Risk Management and Quality Management Systems

  • Integration of risk management into quality management systems
  • Relationship between ISO 14971 and ISO 13485
  • Implementing a risk-based quality management system
  • Continual improvement and effectiveness

Module 9: Risk Communication and Stakeholder Engagement

  • Risk communication principles and strategies
  • Stakeholder identification and engagement
  • Risk information and disclosure
  • Transparency and accountability

Module 10: Certification and Course Wrap-Up

  • Final exam and certification
  • Course review and evaluation
  • Continuing education and professional development
  • Final Q&A and closing remarks


Certificate of Completion

Upon completing this course, participants will receive a Certificate of Completion issued by The Art of Service.



Course Features

  • Interactive and engaging content
  • Comprehensive and up-to-date materials
  • Personalized learning experience
  • Practical and real-world applications
  • High-quality content and expert instructors
  • Certification and recognition
  • Flexible learning options and user-friendly interface
  • Mobile-accessible and community-driven
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
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