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 ...
As an admin who's come up by my own bootstraps, I hear a lot about "change control". I think I probably do it myself, but I'm wondering what other people do and how they approach it. What methods do ...