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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...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 ...

The present publication provides for the first time information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety.

Quality. It’s difficult to assign a single definition to a word that carries many connotations. Instead, let’s look at quality as an experience. There is a vibration to it. It’s palpable. Quality, in ...

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 ...