Integrating Git version control with validation systems automates medical device software traceability, ensuring instant ...

Until recently, safety regulations for medical device software, at least formally, were not exceptionally rigorous across the board. In addition, software was not formally classified as a medical ...

By reframing security as an investment rather than a cost, MDMs can reduce risk exposure, improve compliance readiness, and ...

The FDA recently released six guidance documents as part of the agency’s continued focus on updating the regulatory stance on software as a medical device and other digital health products. The ...

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...

Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (Nov 10th - Nov 11th, 2025)" training has ...

Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and ...

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SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation 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 ...