ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes Awareness Course

1. INTRODUCTION
   ISO 13485:2016 Medical Devices Quality Management Systems is an internationally recognized quality management standard specifically developed for the medical device industry.  It provides a framework for organizations involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g.: technical support) to ensure they consistently meet customer and regulatory requirements.
    
   The standard emphasizes a process-oriented approach, focusing on risk management and the importance of maintaining effective quality management systems (QMS).  By adhering to ISO 13485:2016, organizations can demonstrate their commitment to quality and regulatory compliance, ensuring their products meet stringent safety and performance standards.
    
   ISO 13485:2016 aligns with regulatory requirements and industry best practices, making it an essential tool for any organization aiming to achieve and maintain regulatory compliance.  It addresses various aspects of a QMS, including document control, management responsibility, resource management, product realization, and measurement, analysis, and improvement.
    
   By implementing ISO 13485:2016, medical device manufacturers can ensure the highest level of product safety and efficacy, thereby increasing their market access and customer trust.  This standard supports organizations in meeting stringent regulatory demands and maintaining a robust quality management system within the medical device industry.
    

2. COURSE OBJECTIVES
   The objectives of this training are to provide participants with an interpretation of the ISO 13485:2016 requirements and an understanding of the rationale and foundation of the standard.

3. COURSE CONTENTS
   • Approach and concept in ISO 13485:2016;
   • The ISO 13485:2016 requirements;
   • Quality management system; management responsibility; resource management; product realization; measurement, analysis and improvement;
   • Risk management approach to product development and product realisation;
   • Course summary
      

4. WHO SHOULD ATTEND
   This course is designed for Quality Assurance and Quality Control Personnel, Regulatory Affairs Specialists, Design and Development Engineers, Manufacturing and Production Personnel, Internal Auditors, Management Staff, and any other staff likely to be involved in or currently involved in the implementation of the ISO 13485:2016 Quality Management System.

5. ADMINISTRATIVE DETAILS
   

   Time	: To be advised
   Duration	: To be advised