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 ...

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 ...

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Siemens PAVE360 Automotive, a cloud-based digital twin platform, offers automakers a jump-start in adopting software-defined ...

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 ...

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...

The use of smartphones in healthcare is old news. Despite the decade-old trend, many challenges still exist with utilizing a patient’s smartphone, especially with optimizing both safety and patient ...

The importance of ergonomics in hardware design is easy to grasp, if not always simple to carry out. The end goal is to make a device as easy and comfortable to use as possible, both physically and ...

At CES® 2026, Lenovo™ unveiled a sweeping lineup of innovations across its wide portfolio, introducing smarter new personal ...