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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 ...
With manufacturers, compliance can be both nuisance and profanity or accepted reluctantly as a business cost. Says Senior Research Analyst Alison Smith, of Boston-headquartered AMR Research, “In the ...
Irvine medical software maker Quality Systems Inc. is looking for a boost from federal stimulus spending on electronic medical records in 2011, according to the company’s executives. “We’re hopeful ...
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