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.

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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Software defect prediction and quality assurance are critical fields in modern software engineering that focus on identifying error-prone components early in the development cycle. By utilising ...

Software quality assurance management (QA) is the process of making sure that quality requirements for products or services are fulfilled. Quality assurance methods ensure that all requirements have ...

• Apply software quality assurance methods and techniques and evaluate their effectiveness. This course is designed for software engineers and managers who wish to extend their skills of problem ...

Reliable, safety-critical and trustworthy software plays a crucial role in many of DLR's research areas. It is used, for example, to control satellites, to monitor robots, in autonomous aircraft or to ...

The FDA recalled 60 medical devices last year, and the running total for this year is 56. The good news is that there’s a startup working to make future totals lower. The startup, named Ketryx, ...

Thriving businesses use test management software. After all, every business needs testing to maintain their desired outcomes. This evaluation type also aims to ensure quality or standards of ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Cory Benfield discusses the evolution of ...