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Mastering ISO 13485; A Step-by-Step Guide to Implementing a Robust Quality Management System for Medical Devices

Mastering ISO 13485; A Step-by-Step Guide to Implementing a Robust Quality Management System for Medical Devices

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Mastering ISO 13485: A Step-by-Step Guide to Implementing a Robust Quality Management System for Medical Devices



Course Overview

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485 standard and its application in implementing a robust Quality Management System (QMS) for medical devices. Through interactive lessons, real-world examples, and hands-on projects, participants will gain the knowledge and skills necessary to establish, maintain, and continually improve a QMS that meets the requirements of ISO 13485.



Course Objectives

  • Understand the requirements of ISO 13485 and its application in the medical device industry
  • Develop a comprehensive understanding of the Quality Management System (QMS) and its components
  • Learn how to establish, maintain, and continually improve a QMS that meets the requirements of ISO 13485
  • Understand the importance of risk management and its application in the QMS
  • Develop the skills necessary to conduct internal audits and management review
  • Learn how to prepare for and respond to regulatory audits


Course Outline

Module 1: Introduction to ISO 13485

  • Overview of the ISO 13485 standard
  • History and evolution of the standard
  • Key concepts and principles
  • Relationship with other standards and regulations

Module 2: Quality Management System (QMS) Fundamentals

  • Definition and scope of the QMS
  • QMS components: policies, procedures, and records
  • QMS structure: organizational, processes, and functional
  • Responsibilities and authorities

Module 3: Establishing a QMS

  • Defining the QMS scope and boundaries
  • Establishing the QMS structure and organization
  • Developing QMS policies and procedures
  • Establishing QMS records and documentation

Module 4: Maintaining a QMS

  • Monitoring and measuring QMS performance
  • Conducting internal audits and management review
  • Identifying and addressing nonconformities
  • Continual improvement and corrective action

Module 5: Risk Management

  • Introduction to risk management
  • Risk management principles and concepts
  • Risk assessment and risk control
  • Risk management in the QMS

Module 6: Regulatory Requirements

  • Overview of regulatory requirements for medical devices
  • Regulatory frameworks: FDA, EU, and others
  • Compliance with regulatory requirements
  • Preparing for and responding to regulatory audits

Module 7: Auditing and Management Review

  • Introduction to auditing and management review
  • Conducting internal audits
  • Conducting management review
  • Follow-up and corrective action

Module 8: Continual Improvement

  • Introduction to continual improvement
  • Continual improvement principles and concepts
  • Identifying opportunities for improvement
  • Implementing corrective action and preventive action

Module 9: QMS Metrics and Performance

  • Introduction to QMS metrics and performance
  • Establishing QMS metrics and performance indicators
  • Monitoring and measuring QMS performance
  • Using data to drive continual improvement

Module 10: QMS Documentation and Record Keeping

  • Introduction to QMS documentation and record keeping
  • QMS documentation requirements
  • QMS record keeping requirements
  • Best practices for QMS documentation and record keeping

Module 11: QMS Implementation and Transition

  • Introduction to QMS implementation and transition
  • Planning and executing QMS implementation
  • Transitioning to a new QMS
  • Lessons learned and best practices

Module 12: QMS Certification and Surveillance

  • Introduction to QMS certification and surveillance
  • QMS certification process
  • QMS surveillance and recertification
  • Maintaining QMS certification

Module 13: QMS Auditing and Compliance

  • Introduction to QMS auditing and compliance
  • QMS auditing principles and concepts
  • Conducting QMS audits
  • Compliance with regulatory requirements

Module 14: QMS Risk Management and Mitigation

  • Introduction to QMS risk management and mitigation
  • QMS risk management principles and concepts
  • Identifying and assessing QMS risks
  • Mitigating and controlling QMS risks

Module 15: QMS Corrective Action and Preventive Action

  • Introduction to QMS corrective action and preventive action
  • QMS corrective action principles and concepts
  • QMS preventive action principles and concepts
  • Implementing corrective action and preventive action


Certificate of Completion

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



Course Features

  • Interactive and engaging lessons
  • Comprehensive and up-to-date content
  • Practical and real-world applications
  • Expert instructors with industry experience
  • Personalized learning experience
  • Flexible learning schedule
  • User-friendly and mobile-accessible platform
  • Community-driven discussion forum
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
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