In a follow-up to their prior working paper, Brian Miller, William Blanks, and Brian Yagi published a review of 510(k) Third Party Review Program in the Journal of Medical Systems. In their article, ...

Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices ...

Third-party relationships are double-edged swords— they can be your most significant force multipliers or risks. Third-party vendors are ingrained in all aspects of an organization, from accountants ...

Managing external partners has become a critical part of doing business today. As companies expand and rely more on outsourcing, the risks tied to outside vendors grow larger. Businesses can face ...

Meta has “paused” its initiative to bring third-party Horizon OS headsets to the market. The company says it has shifted focus to “building the world-class first-party hardware and software needed to ...

Nearly 20 third-party games are being added to the Epic Games Store on Android and iOS. The mobile store is also launching a free games program. Epic claims that the 100 highest-grossing mobile game ...