ISO 13485:2016 - Medical Devices - Quality Management Systems

ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) specifically for the medical device industry. This training is designed to provide participants with a comprehensive understanding of the ISO 13485:2016 requirements, its implementation within business processes, and alignment with national regulations such as CDAKB (Good Distribution Practices for Medical Devices) and CPAKB (Good Manufacturing Practices for Medical Devices) in Indonesia.

Participants will gain knowledge of the fundamental concepts, clause interpretations, required documentation, and effective internal audit techniques based on the standard. This training is highly recommended for medical device manufacturers, distributors, and service providers aiming to ensure the safety, effectiveness, and regulatory compliance of their products.