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ISO 14971; A Complete Guide to Risk Management for Medical Devices - Practical Tools for Self-Assessment

ISO 14971; A Complete Guide to Risk Management for Medical Devices - Practical Tools for Self-Assessment

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ISO 14971: A Complete Guide to Risk Management for Medical Devices - Practical Tools for Self-Assessment



Course Overview

This comprehensive course provides a detailed understanding of the principles and practices of risk management for medical devices, as outlined in the ISO 14971 standard. Participants will learn how to identify, analyze, and mitigate risks associated with medical devices, and how to implement a risk management system that meets regulatory requirements.



Course Objectives

  • Understand the principles and requirements of ISO 14971
  • Learn how to identify and analyze risks associated with medical devices
  • Understand how to mitigate and manage risks
  • Implement a risk management system that meets regulatory requirements
  • Apply practical tools for self-assessment


Course Outline

Module 1: Introduction to Risk Management

  • Definition of risk management
  • Importance of risk management in medical devices
  • Overview of ISO 14971

Module 2: Risk Management Principles

  • Risk management process
  • Risk assessment
  • Risk mitigation
  • Risk review and update

Module 3: Risk Identification

  • Hazard identification
  • Hazard analysis
  • Risk estimation

Module 4: Risk Analysis

  • Qualitative risk analysis
  • Quantitative risk analysis
  • Semi-quantitative risk analysis

Module 5: Risk Mitigation

  • Risk reduction
  • Risk avoidance
  • Risk transfer

Module 6: Risk Management System

  • Risk management policy
  • Risk management procedure
  • Risk management records

Module 7: Regulatory Requirements

  • EU MDR
  • EU IVDR
  • US FDA

Module 8: Practical Tools for Self-Assessment

  • Risk management checklist
  • Risk assessment template
  • Risk mitigation plan template

Module 9: Case Studies

  • Real-world examples of risk management in medical devices
  • Group discussions and exercises

Module 10: Certification and Final Assessment

  • Final exam
  • Certificate issuance


Course Features

  • Interactive: Engaging video lessons, interactive quizzes, and group discussions
  • Comprehensive: Covers all aspects of risk management for medical devices
  • Personalized: Self-paced learning with flexible schedule
  • Up-to-date: Latest regulatory requirements and industry best practices
  • Practical: Real-world examples and case studies
  • Expert instructors: Experienced professionals in risk management and medical devices
  • Certification: Certificate issued upon completion
  • Flexible learning: Accessible on desktop, tablet, or mobile device
  • User-friendly: Easy-to-use online platform
  • Community-driven: Discussion forum for networking and Q&A
  • Actionable insights: Practical tools and templates for self-assessment
  • Hands-on projects: Real-world exercises and group discussions
  • Bite-sized lessons: Short, focused video lessons
  • Lifetime access: Access to course materials forever
  • Gamification: Engaging quizzes and challenges
  • Progress tracking: Track your progress and stay motivated


Certificate

Upon completion of the course, participants will receive a certificate issued by The Art of Service. This certificate demonstrates that the participant has achieved a comprehensive understanding of risk management for medical devices and has the skills and knowledge to implement a risk management system that meets regulatory requirements.

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