Awareness Training Program Based on ISO 13485:2016 Standard (Medical Device)
ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system
This programme will provide participants an insight of the ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes).
Preferred to have basic knowledge in Quality Management system and / or experience if medical device, Pharmaceutical operations.
Certificate of participation