Dr Gang Shen is a postdoctoral researcher specialising in medical device design, fabrication, and testing, based at University College Dublin (UCD). He completed his PhD at UCD, where his research focused on improving the tribological performance of bioimplants. His primary research interests lie in the precision manufacturing and setting up customized testing methods.
Technical Summary
The transition of medical device prototypes to reliable and cost-effective mass production presents significant technical and manufacturing challenges. Concurrently, the development of customized in-line verification methodologies is essential to ensure that devices are manufactured in strict accordance with Product Requirement Specifications (PRS), to systematically evaluate device performance and safety, and to demonstrate compliance with relevant regulatory standards. This study aims to establish a customized mass-production framework that incorporates integrated in-line verification and validation processes.