India has brought AI-based diagnostic software under medical device regulations, mandating government licences and clinical ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Propel Software, creator of the first product value management (PVM) platform that transforms how businesses create, market, sell, and service products, has ...

Federal regulators are advising regulated healthcare firms and their third-party vendors to harden systems, software and ...

A monthly overview of things you need to know as an architect or aspiring architect. Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

The survey conducted across consumer goods, high tech, industrial equipment, and medical device industries found medical device companies passing up the ability to streamline product operations with ...

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...