Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

Enlil and Interlynk join forces to transform SBOMs into dynamic tools for managing cybersecurity in medical devices.

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 ...

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML evaluation and algorithm change management: CDSCO guidelines ...

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 ...

Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to roll out despite fears the ...

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD).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 rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will navigate a growing pool of wearables.

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