ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical device industry. Its primary goal is to ensure that organizations consistently design, develop, produce, and deliver medical devices that meet regulatory and customer requirements while ensuring patient safety. One of the critical aspects of ISO 13485 is the validation of processes for production and service provision. In the medical device sector, not every process can be verified by measuring or testing the final product alone. Some processes require validation to demonstrate that they can consistently produce outcomes that meet predetermined specifications. This article explores the validation requirements under ISO 13485 and their significance, while also highlighting t ... 更多