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 ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

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 ...

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 ...

Embedded systems are used in many things from cars to medical devices to home security systems and are becoming increasingly popular in our daily lives. They are becoming integral to our familiar ...

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On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). 1 The ...

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 ...

Understanding best practices for mobile device security in today’s healthcare environment can be challenge for many organizations. As mobile devices such as tablets and smartphones become more ...

Software security is very vital, and developers must give it due attention. Over the years, software development has become an important aspect of our lives as we use it for almost everything.

Headlines today obsess over tariffs squeezing margins for medical device manufacturers (MDMs). But while tariffs can shave profits, insecure software can obliterate them—and result in patient safety ...