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 ...

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

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 ...

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 ...

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 ...

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 ...

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

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