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 ...
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” ...
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 ...
A medical device manufacturer ditched a clunky ERP module for quality inspection, opting instead for specialized statistical process control software. Upgrading to new software costs time and money ...