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 ...

Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of ...

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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...

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The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD).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 ...

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support Software (2026 CDS ...

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

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...

Medical device manufacturers are increasingly implementing integrated mobile software and device applications to automate the inventory management process. By doing so, companies can better track ...

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