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” ...

On April 3, 2023, FDA released the draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...

I'm looking for some good change control software that's web based and utilizes SQL server. I used one a couple of years ago and can't recall the name. Google didn't turn up much that looked ...

Most everyone knows networked multifunction printers can pose a dangerous weak link within an enterprise, but not everyone agrees on just how to secure them. Printer manufacturer Sharp upped the ante ...

Let me be clear from the outset: this is not an argument against upgrading. Progress matters. New capabilities matter. Security improvements matter. What’s dangerous is not upgrading, but upgrading by ...