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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 ...
Building systems that enhance resilience, earn trust and accelerate innovation is a true competitive advantange.
Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...
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