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 ...

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 ...

Last month, the federal government announced a major overhaul of the Federal Risk and Authorization Management Program (“FedRAMP”) called “FedRAMP 20x” (we discussed the initiative here). FedRAMP 20x ...