ROCHESTER, Mich.--(BUSINESS WIRE)--OneStream Software, a leader in corporate performance management (CPM) solutions for mid-sized to very large enterprises, announced a new OneStream MarketPlace ...
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 ...
On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...
Software-related recalls have jumped 111% since 2010. Here's what's behind the increase. Joshua R. Dix, Suraj Ramachandran, Darin S. Oppenheimer Editor's Note: This is the second installment in a four ...