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

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 ...

A DevOps-based framework integrates automation, continuous integration, and agile methodologies to enhance medical device software development.

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 ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

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MES software is transforming medical plastics manufacturing by automating compliance and enabling real-time traceability.

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 ...

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 ...

Researchers say they have found more than a dozen vulnerabilities in software used in medical devices and machinery used in other industries that, if exploited by a hacker, could cause critical ...

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...