ISO 13485 Training
This standard is a cornerstone for quality management in the medical device industry. Our training program covers the core principles and practices required for compliance with ISO 13485, focusing on the development and maintenance of a robust quality management system. Participants will gain a a deep understanding of how to ensure product safety, efficacy, and compliance with regulatory requirements.
At the end of the presentation participants should be able to do the following:
• Understand the philosophy and principles of Quality Management System (QMS) for Medical Devices.
• Aware of Fundamental concepts and QMS Requirements of the overall activities carried out by the facility.
• Understand the key factors and the importance of developing the QMS for the organization.
Overview of QMS For Medical Devices
History and background of changes
Important point in ISO 13485:2016
Key Factor of QMS for Medical Devices
Introduction of ISO 13485:2016
Walk through the clauses of ISO 13485:2016