Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a ...

Jon Herlocker, co-founder and CEO of Tignis, sat down with Semiconductor Engineering to talk about how AI in advanced process control reduces equipment variability and corrects for process drift. What ...

Data is an integral part of our lives. Contrary to the past, where files had to be removed periodically to free up storage space, we now assume that our data will never be deleted. Why risk deleting ...

Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...