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ISO 13485 Certification Masterclass for Medical Device Quality Management Systems

ISO 13485 Certification Masterclass for Medical Device Quality Management Systems

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ISO 13485 Certification Masterclass for Medical Device Quality Management Systems

Join our comprehensive course and gain in-depth knowledge of ISO 13485 certification for medical device quality management systems. Upon completion, receive a certificate issued by The Art of Service.



Course Overview

This interactive and engaging course is designed to provide a thorough understanding of ISO 13485 and its application in medical device quality management systems. The curriculum is organized into the following chapters:

Module 1: Introduction to ISO 13485

This module provides an overview of the ISO 13485 standard and its significance in the medical device industry.

  • History and evolution of ISO 13485
  • Key principles and benefits of ISO 13485
  • Relationship between ISO 13485 and other quality management standards
  • Regulatory requirements and ISO 13485

Module 2: Quality Management System (QMS) Fundamentals

This module covers the fundamental concepts of a quality management system and its application in the medical device industry.

  • QMS definitions and terminology
  • QMS principles and framework
  • QMS documentation and record-keeping
  • QMS implementation and maintenance

Module 3: ISO 13485 Requirements

This module provides an in-depth review of the ISO 13485 standard and its requirements.

  • Clause 4: Quality management system
  • Clause 5: Management responsibility
  • Clause 6: Resource management
  • Clause 7: Product realization
  • Clause 8: Measurement, analysis, and improvement

Module 4: Medical Device Quality Management Systems

This module explores the application of ISO 13485 in medical device quality management systems.

  • Medical device regulations and standards
  • Medical device quality management system requirements
  • Design and development controls for medical devices
  • Production and service controls for medical devices

Module 5: Risk Management and ISO 14971

This module covers the principles and application of risk management in medical device quality management systems.

  • Risk management definitions and terminology
  • ISO 14971 and risk management requirements
  • Risk assessment and mitigation
  • Risk management documentation and record-keeping

Module 6: Design and Development Controls

This module provides an in-depth review of design and development controls for medical devices.

  • Design and development planning
  • Design and development inputs and outputs
  • Design and development reviews and verification
  • Design and development validation and transfer

Module 7: Production and Service Controls

This module covers the principles and application of production and service controls for medical devices.

  • Production planning and control
  • Production and service delivery
  • Production and service monitoring and measurement
  • Production and service nonconformity and corrective action

Module 8: Measurement, Analysis, and Improvement

This module explores the principles and application of measurement, analysis, and improvement in medical device quality management systems.

  • Monitoring and measurement of quality management system performance
  • Analysis and evaluation of quality management system data
  • Continual improvement and corrective action
  • Quality management system audit and review

Module 9: Internal Audits and Management Review

This module provides an overview of internal audits and management review in medical device quality management systems.

  • Internal audit principles and planning
  • Internal audit execution and reporting
  • Management review and quality management system evaluation
  • Continual improvement and corrective action

Module 10: ISO 13485 Certification and Implementation

This module covers the principles and application of ISO 13485 certification and implementation.

  • ISO 13485 certification process and requirements
  • Implementation planning and project management
  • Gap analysis and readiness assessment
  • Certification audit and surveillance


Course Benefits

Upon completion of this course, participants will:

  • Gain a comprehensive understanding of ISO 13485 and its application in medical device quality management systems
  • Understand the requirements and principles of a quality management system
  • Learn how to implement and maintain a quality management system that meets ISO 13485 requirements
  • Understand the importance of risk management and its application in medical device quality management systems
  • Receive a certificate issued by The Art of Service upon completion
This course is designed to be interactive, engaging, comprehensive, personalized, up-to-date, practical, and applicable to real-world scenarios. With expert instructors, high-quality content, and a user-friendly platform, participants will gain actionable insights and hands-on experience. The course is also mobile-accessible, community-driven, and includes gamification and progress tracking.

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