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 ...

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 ...

A white paper aims to help companies design, launch and maintain safe AI‑enabled medical devices across global markets.

A new whitepaper by regulatory experts IMed Group and life science software developers Firefinch SoftwareOxford, 12th ...

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 ...

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 ...

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 ...

Has CDSCO Guidance Changed The Rules? Legal News and Analysis - India - Regulatory & Compliance - Conventus Law ...

Machine design engineers working in the medical device field might draw inspiration from AuraWell’s iterative, ...