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ISO 13485 Quality Management System; Mastering Compliance and Risk Management for Medical Devices

ISO 13485 Quality Management System; Mastering Compliance and Risk Management for Medical Devices

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ISO 13485 Quality Management System: Mastering Compliance and Risk Management for Medical Devices



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485 Quality Management System, with a focus on mastering compliance and risk management for medical devices. Participants will gain the knowledge and skills necessary to implement and maintain a quality management system that meets the requirements of ISO 13485.



Course Objectives

  • Understand the requirements of ISO 13485 and its application to medical devices
  • Learn how to implement and maintain a quality management system that meets the requirements of ISO 13485
  • Understand the principles of risk management and how to apply them to medical devices
  • Gain the knowledge and skills necessary to conduct internal audits and management reviews
  • Understand the importance of continuous improvement and how to implement it in a quality management system


Course Outline

Module 1: Introduction to ISO 13485

  • Overview of ISO 13485
  • History and development of ISO 13485
  • Key principles and concepts of ISO 13485
  • Relationship between ISO 13485 and other regulatory requirements

Module 2: Quality Management System Requirements

  • Quality policy and objectives
  • Quality manual and procedures
  • Organization and management structure
  • Responsibilities and authorities
  • Human resources and training
  • Infrastructure and work environment

Module 3: Risk Management

  • Principles of risk management
  • Risk assessment and analysis
  • Risk evaluation and control
  • Risk monitoring and review
  • Risk management tools and techniques

Module 4: Design and Development

  • Design and development planning
  • Design and development inputs
  • Design and development outputs
  • Design and development review
  • Design and development verification and validation

Module 5: Production and Service Provision

  • Production planning and control
  • Service provision planning and control
  • Validation of processes
  • Identification and traceability
  • Customer property

Module 6: Measurement, Analysis, and Improvement

  • Measurement and monitoring
  • Analysis and evaluation
  • Improvement and corrective action
  • Preventive action
  • Continuous improvement

Module 7: Internal Audits and Management Reviews

  • Internal audit planning and preparation
  • Internal audit execution and reporting
  • Management review planning and preparation
  • Management review execution and reporting

Module 8: Certification and Accreditation

  • Certification and accreditation requirements
  • Certification and accreditation process
  • Maintaining certification and accreditation


Course Features

  • Interactive and engaging: The course includes interactive lessons, quizzes, and games to keep participants engaged and motivated.
  • Comprehensive and personalized: The course covers all aspects of ISO 13485 and provides personalized feedback and guidance.
  • Up-to-date and practical: The course includes the latest developments and best practices in quality management and risk management for medical devices.
  • Real-world applications: The course includes real-world examples and case studies to illustrate the application of ISO 13485.
  • High-quality content: The course includes high-quality video lessons, animations, and graphics.
  • Expert instructors: The course is taught by expert instructors with extensive experience in quality management and risk management for medical devices.
  • Certification: Participants receive a certificate upon completion of the course, issued by The Art of Service.
  • Flexible learning: The course is available online and can be accessed at any time and from any location.
  • User-friendly: The course is easy to navigate and includes a user-friendly interface.
  • Mobile-accessible: The course can be accessed on mobile devices.
  • Community-driven: The course includes a community forum where participants can connect with each other and with the instructors.
  • Actionable insights: The course provides actionable insights and practical advice that can be applied immediately.
  • Hands-on projects: The course includes hands-on projects and exercises to help participants apply their knowledge and skills.
  • Bite-sized lessons: The course includes bite-sized lessons that can be completed in a short amount of time.
  • Lifetime access: Participants have lifetime access to the course materials and can review them at any time.
  • Gamification: The course includes gamification elements, such as points and badges, to make learning fun and engaging.
  • Progress tracking: The course includes progress tracking and reporting to help participants stay on track.
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