To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial. Timothy Cuff and Steven ...

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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 ...

Structural flaws are hiding in plain sight, and a shift is long overdue, writes Pujitha Gourabathini at Becton, Dickinson and ...

Remote devices require engineering effort to ensure these systems remain safe, reliable, and secure in a wide range of ...

Formal methods provide a rigorous mathematical foundation for the specification, development and verification of medical device software. This approach enhances both reliability and safety, which are ...

Neural implants promise advanced patient therapies. But the products' security and privacy risks demand stronger design ...

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 ...

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 ...

ISG has launched a study examining service providers that help medical device companies adopt new technologies and enhance their products.