Skip to main content
Mastering ISO 13485; A Step-by-Step Guide to Ensuring Medical Device Quality Management and Regulatory Compliance

Mastering ISO 13485; A Step-by-Step Guide to Ensuring Medical Device Quality Management and Regulatory Compliance

$199.00
When you get access:
Course access is prepared after purchase and delivered via email
How you learn:
Self-paced • Lifetime updates
Your guarantee:
30-day money-back guarantee — no questions asked
Who trusts this:
Trusted by professionals in 160+ countries
Adding to cart… The item has been added

Mastering ISO 13485: A Step-by-Step Guide to Ensuring Medical Device Quality Management and Regulatory Compliance

Mastering ISO 13485: A Step-by-Step Guide to Ensuring Medical Device Quality Management and Regulatory Compliance

This comprehensive course is designed to provide participants with a thorough understanding of the ISO 13485 standard and its application in ensuring medical device quality management and regulatory compliance. Upon completion of this course, participants will receive a certificate issued by The Art of Service.



Course Overview

This course is designed to be interactive, engaging, comprehensive, personalized, up-to-date, practical, and applicable to real-world scenarios. The course content is of high quality, and the expert instructors will guide participants through the course material. The course is flexible and can be accessed on various devices, including mobile phones and tablets. Participants will have lifetime access to the course material and will be able to track their progress.



Course Outline

Module 1: Introduction to ISO 13485

  • Overview of ISO 13485: History, purpose, and scope of the standard
  • Key Concepts and Principles: Definition of quality management, medical devices, and regulatory requirements
  • Benefits of Implementing ISO 13485: Improved quality, increased efficiency, and enhanced regulatory compliance

Module 2: Quality Management System (QMS) Requirements

  • QMS Framework: Establishing, implementing, maintaining, and continually improving the QMS
  • Quality Policy and Objectives: Defining and documenting the quality policy and objectives
  • Organizational Structure and Responsibilities: Defining roles, responsibilities, and authorities

Module 3: Design and Development Requirements

  • Design and Development Planning: Defining design and development stages and milestones
  • Design and Development Inputs: Identifying and documenting design and development inputs
  • Design and Development Outputs: Documenting design and development outputs

Module 4: Production and Service Provision Requirements

  • Production Planning and Control: Planning and controlling production processes
  • Service Provision Planning and Control: Planning and controlling service provision processes
  • Identification and Traceability: Identifying and tracing products and services

Module 5: Measurement, Analysis, and Improvement Requirements

  • Monitoring and Measurement: Monitoring and measuring QMS performance
  • Analysis and Evaluation: Analyzing and evaluating QMS performance
  • Continual Improvement: Identifying and implementing improvements

Module 6: Regulatory Requirements

  • Regulatory Framework: Overview of regulatory requirements for medical devices
  • Compliance with Regulatory Requirements: Ensuring compliance with regulatory requirements
  • Regulatory Audits and Inspections: Preparing for regulatory audits and inspections

Module 7: Auditing and Certification

  • Auditing Principles and Techniques: Understanding auditing principles and techniques
  • Internal Audits: Conducting internal audits
  • Certification and Surveillance Audits: Preparing for certification and surveillance audits

Module 8: Implementation and Maintenance

  • Implementation Planning: Planning the implementation of the QMS
  • Training and Awareness: Providing training and awareness on the QMS
  • Continual Improvement and Maintenance: Maintaining and continually improving the QMS


Course Features

  • Interactive and Engaging: The course is designed to be interactive and engaging, with quizzes, games, and hands-on activities
  • Comprehensive and Personalized: The course is comprehensive and personalized, with expert instructors guiding participants through the course material
  • Up-to-Date and Practical: The course is up-to-date and practical, with real-world examples and case studies
  • High-Quality Content: The course content is of high quality, with expert instructors and a rigorous quality control process
  • Expert Instructors: The course instructors are experts in the field of ISO 13485 and quality management
  • Certification: Participants will receive a certificate upon completion of the course, issued by The Art of Service
  • Flexible Learning: The course is flexible and can be accessed on various devices, including mobile phones and tablets
  • User-Friendly: The course is user-friendly, with a simple and intuitive interface
  • Mobile-Accessible: The course is mobile-accessible, allowing participants to access the course material on-the-go
  • Community-Driven: The course is community-driven, with a community of participants and instructors providing support and guidance
  • Actionable Insights: The course provides actionable insights and practical advice, allowing participants to apply the knowledge and skills learned in the course
  • Hands-On Projects: The course includes hands-on projects and activities, allowing participants to apply the knowledge and skills learned in the course
  • Bite-Sized Lessons: The course is divided into bite-sized lessons, allowing participants to learn at their own pace
  • Lifetime Access: Participants will have lifetime access to the course material, allowing them to review and refresh their knowledge and skills at any time
  • Gamification: The course includes gamification elements, such as quizzes and games, to make the learning experience more engaging and fun
  • Progress Tracking: The course includes progress tracking, allowing participants to track their progress and stay motivated
,
!