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 ...

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 ...

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 ...

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 integration of third-party components and software is an increasingly critical area of security risk that needs more attention from medical device manufacturers, says Anura Fernando, global head ...

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

Heart disease patients like Dick Cheney are vulnerable to buggy software and hack-attacks aimed straight at the devices implanted near their hearts. Worse, they have no legal recourse. But open source ...

As we know, companies can find themselves in hot water at times with the FDA when it comes to regulations and procedures around complaint management, which can be a mess to straighten out. Medical ...