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Mastering ISO 14971; A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety

Mastering ISO 14971; A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety

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Mastering ISO 14971: A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety

Mastering ISO 14971: A Step-by-Step Guide to Conducting Effective Risk Management and Ensuring Medical Device Safety



Course Overview

This comprehensive course provides a step-by-step guide to conducting effective risk management and ensuring medical device safety in accordance with ISO 14971. Participants will receive a certificate upon completion issued by The Art of Service.



Course Features

  • Interactive: Engage with interactive lessons and activities to enhance your learning experience.
  • Engaging: Enjoy a user-friendly interface and bite-sized lessons to keep you engaged.
  • Comprehensive: Cover all aspects of ISO 14971 and risk management for medical devices.
  • Personalized: Get personalized feedback and support from expert instructors.
  • Up-to-date: Stay up-to-date with the latest developments and best practices in risk management.
  • Practical: Apply your knowledge to real-world scenarios and case studies.
  • Real-world applications: Learn from real-world examples and case studies.
  • High-quality content: Access high-quality content developed by expert instructors.
  • Expert instructors: Learn from experienced instructors with expertise in risk management and medical devices.
  • Certification: Receive a certificate upon completion issued by The Art of Service.
  • Flexible learning: Learn at your own pace and on your own schedule.
  • User-friendly: Enjoy a user-friendly interface and easy navigation.
  • Mobile-accessible: Access the course on your mobile device or tablet.
  • Community-driven: Join a community of professionals and connect with peers.
  • Actionable insights: Gain actionable insights and practical tips to apply to your work.
  • Hands-on projects: Complete hands-on projects to apply your knowledge and skills.
  • Bite-sized lessons: Learn in bite-sized chunks to fit your busy schedule.
  • Lifetime access: Enjoy lifetime access to the course materials and updates.
  • Gamification: Engage with gamification elements to make learning fun and engaging.
  • Progress tracking: Track your progress and stay motivated.


Course Outline

Module 1: Introduction to ISO 14971

  • Overview of ISO 14971
  • History and development of the standard
  • Key concepts and terminology
  • Relationship with other standards and regulations

Module 2: Risk Management Principles

  • Definition of risk and risk management
  • Risk management principles and framework
  • Identification and analysis of hazards
  • Risk evaluation and control

Module 3: Risk Management Process

  • Risk management process overview
  • Risk identification and analysis
  • Risk evaluation and prioritization
  • Risk control and mitigation
  • Risk review and update

Module 4: Hazard Identification and Analysis

  • Hazard identification techniques
  • Hazard analysis and risk estimation
  • Failure mode and effects analysis (FMEA)
  • Fault tree analysis (FTA)

Module 5: Risk Evaluation and Control

  • Risk evaluation criteria and methods
  • Risk control and mitigation strategies
  • Design and implementation of risk controls
  • Verification and validation of risk controls

Module 6: Risk Management for Medical Devices

  • Medical device risk management overview
  • Risk management for medical device design
  • Risk management for medical device manufacturing
  • Risk management for medical device post-market surveillance

Module 7: ISO 14971 Implementation and Certification

  • ISO 14971 implementation process
  • Gap analysis and readiness assessment
  • Implementation planning and project management
  • Certification audit and maintenance

Module 8: Auditing and Compliance

  • Auditing principles and techniques
  • Compliance with ISO 14971 and regulatory requirements
  • Audit planning and preparation
  • Audit execution and reporting

Module 9: Risk Management Tools and Techniques

  • Risk management software and tools
  • Failure mode and effects analysis (FMEA) software
  • Fault tree analysis (FTA) software
  • Sensitivity analysis and simulation

Module 10: Case Studies and Best Practices

  • Real-world case studies and examples
  • Best practices for risk management and ISO 14971 implementation
  • Lessons learned and common pitfalls
  • Future trends and developments in risk management


Certificate of Completion

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

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