Designed with ease of use in mind, the software modernizes the graphical user interface while retaining the rigorous and robust calculation engine from the company's Connoisseur APC (Advanced Process ...

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 ...

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” ...

In large software organizations, even a small change can affect thousands of users. Managing changes like ensuring updates are smooth, safe, and well-communicated, is a delicate process that defines ...