Introduction
  • Introduction to the Instructor
  • Introduction to the ISO 13485:2016 Medical Devices' QMS Standard
  • Applicability of ISO 13485 - Not a Point to Ignore!
  • Guidance on ISO 13485 - Clause 1
  • References to ISO 13485 & Guidance to References - Clause 2
  • Interesting Quiz
The Basic Concepts in ISO 13485:2016
  • Introduction to Clause 3
  • Medical Devices' Industry Specific Terms Part 1
  • Medical Devices' Industry Specific Terms Part 2
  • Medical Devices' Industry Specific Terms Part 3
  • Medical Devices' Industry Specific Terms Part 4
Quality Management System (QMS) - The Auditable Requirements
  • Summary of QMS Requirements & General Guidelines
  • Documentation Requirements of QMS
  • What you think about QMS Documentation?
  • Management Responsibility
  • Planning, Authorities and Reviews for QMS
  • Resource Management
  • Work Environment
Medical Devices' QMS - The Auditable Requirements
  • Planning of Product Realization with Customer Focus
  • Design and Development Initial Protocols
  • D&D Review, Verification & Validation
  • D&D Transfer & Files
  • Purchasing Process
Production, Services, and Measurement Analysis - The Auditable Requirements
  • Production & Service Provision Part 1
  • Production & Service Provision Part 2
  • Production & Service Provision Part 3
  • Control of Monitoring & Measuring Equipment
  • Measurement and Analysis
  • Measurement and Analysis Part 2
  • Analysis & Improvement
  • Applying for Exoexcellence Certificate