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 ...

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 ...

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...

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 ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...

Despite the fresh set of guidelines, experts said that technologies like AI are increasingly being used in MedTech sector, ...

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 ...

Beyond the standards and frameworks, how do secure-by-design tenets become practical, repeatable and scalable?

The collaboration will facilitate the provision of secure over-the-air software updates for connected devices.

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 ...