On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
ABERDEEN PROVING GROUND, Md. – The world of cybersecurity is an ever-changing one. New threats constantly appear which can attack software whether it’s in your home computer or on the Army’s tactical ...
The Computer Software Assurance (CSA) industry is experiencing rapid digital transformation as organizations prioritize robust software validation and compliance. Growing regulatory mandates and the ...