Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

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The goal of medical device software development should be to select a process and architecture that ensure a safe and effective product. The methods utilized to achieve this goal differ among medical ...

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

Secure by design didn’t just pop up in the medical device industry with the update to the Food & Drug Administration (FDA) guidance on cybersecurity recommendations. However, its inclusion in this ...

Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...

The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the ...

Early-stage development in technology usually follows a “fail fast” philosophy: build something simple, observe outcomes, and ...

Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...

The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...