Delaying QMS implementation—especially for design controls and the Design History File (DHF)—creates costly documentation gaps, audit vulnerability, and remediation expenses that often exceed $100,000 ...

Rep. Pramila Jayapal of Washington, a prominent House Democrat, is alleging that Attorney General Pam Bondi “spied” on her online searches while she was reviewing documents related to Jeffrey Epstein.

Attorney General Pam Bondi at a House Judiciary Committee hearing seemed to have a printout of Rep. Pramila Jayapal's history of searches of the Department of Justice's database of documents related ...

Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).

The context-aware, multi-lingual AI agents act like a 24/7 digital FDA reviewer, helping MedTech companies improve first-time 510(k) submission success rates. FDA reviewers look for a consistent ...