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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...
Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...
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 ...
Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback