What does the term 'manufacturing site' refer to?

The term 'manufacturing site' refers to the location where a medical device is produced. This definition encompasses all the activities necessary for transforming raw materials into final products, including assembly, packaging, and any related processes required to meet regulatory standards and ensure product quality. In the context of regulatory affairs, it's critical for compliance and inspection purposes, as different regulatory bodies may inspect manufacturing sites to ensure that they adhere to relevant Good Manufacturing Practices (GMP) and quality management system requirements.

Marketing and device testing are distinct from manufacturing. The place where device marketing occurs is separate from the production location, and while device testing may occur at various sites, it is not synonymous with the manufacturing process itself. Similarly, the headquarters of the manufacturing company is often more administrative and strategic in nature rather than being a physical location where devices are actively produced. Hence, 'manufacturing site' is specifically focused on the actual production of medical devices.