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 ...

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 ...

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In-house and private practice counsel set out the challenges and opportunities of protecting software in medical devices and software as a medical device Medical device manufacturers have been ...

PISCATAWAY, N.J.--(BUSINESS WIRE)--IEEE, the world's largest professional organization dedicated to advancing technology for humanity, today announced the release of Building Code for Medical Device ...

CAMBRIDGE, England, Feb. 12, 2019 /PRNewswire/ -- The complex relationship between opportunity and risk in the connected world poses unprecedented challenges for medical device manufacturers, ...

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

On November 4, 2021, FDA released a draft guidance for public comment entitled “Content of Premarket Submissions for Device Software Functions” (the “2021 Draft Guidance”). In its final form, this ...

The initiative aims to help innovators refine these devices for large-scale production, prepare them for commercial use, and ...

The internet of medical things (IoMT) is many things to many people. However, for developers and device manufacturers, it's a pain. The question was asked if regulation was killing innovation in ...

On June 7, 2024, the Court of Appeals for the DC Circuit in Medical Imaging & Technology Alliance et al. v. Library of Congress et al., No. 23-5067 (D.C. Cir.), vacated an earlier district court ...