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ISO 13485 Compliance Mastery for Medical Device Organizations

ISO 13485 Compliance Mastery for Medical Device Organizations

$199.00
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ISO 13485 Compliance Mastery for Medical Device Organizations

Gain comprehensive knowledge and skills to implement and maintain a Quality Management System (QMS) that meets the requirements of ISO 13485:2016. Upon completion, participants will receive a Certificate of Completion issued by The Art of Service.



Course Overview

This extensive and detailed course curriculum is designed to provide medical device organizations with the knowledge and skills necessary to achieve ISO 13485 compliance. The course is organized into 8 chapters, covering over 80 topics, and is delivered in an interactive, engaging, and comprehensive manner.



Course Outline

Chapter 1: Introduction to ISO 13485

  • Overview of ISO 13485:2016
  • History and evolution of the standard
  • Key principles and concepts
  • Benefits of ISO 13485 certification
  • Regulatory requirements and compliance

Chapter 2: Quality Management System (QMS) Fundamentals

  • QMS definition and scope
  • QMS policies and objectives
  • QMS documentation and records
  • QMS implementation and maintenance
  • QMS monitoring and continuous improvement

Chapter 3: ISO 13485:2016 Requirements

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

Chapter 4: Risk Management

  • Risk management principles and concepts
  • Risk assessment and analysis
  • Risk control and mitigation
  • Risk monitoring and review
  • Risk management documentation and records

Chapter 5: Design and Development

  • Design and development planning
  • Design and development inputs and outputs
  • Design and development review and verification
  • Design and development validation and transfer
  • Design and development documentation and records

Chapter 6: Production and Service Provision

  • Production and service provision planning
  • Production and service provision controls
  • Production and service provision documentation and records
  • Production and service provision monitoring and measurement
  • Production and service provision continuous improvement

Chapter 7: Control of External Providers

  • External provider controls
  • External provider evaluation and selection
  • External provider monitoring and review
  • External provider documentation and records
  • External provider continuous improvement

Chapter 8: Auditing and Certification

  • Auditing principles and concepts
  • Audit planning and preparation
  • Audit execution and reporting
  • Certification process and requirements
  • Maintaining certification and continuous improvement


Course Features

  • Interactive and engaging learning experience
  • Comprehensive and up-to-date content
  • Personalized learning approach
  • Practical and real-world applications
  • High-quality content and expert instructors
  • Certification upon completion
  • Flexible learning schedule
  • User-friendly and mobile-accessible platform
  • Community-driven discussion forums
  • Actionable insights and hands-on projects
  • Bite-sized lessons and lifetime access
  • Gamification and progress tracking
Join this comprehensive course to gain the knowledge and skills necessary to achieve ISO 13485 compliance and improve your organization's quality management system.

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