• Software As a Medical Device

    April 18, 2023

    Move over, Dr House, there's a new diagnostician in town, and it's not human! Thanks to the power of AI, medical devices are becoming smarter than ever, analyzing data faster than ever and creating regulatory [...]

  • Software as a Medical Device

    January 24, 2023

    The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of technology to medical devices. While medical testing devices, scans, and robotic surgical [...]

  • Software as a Medical Device

    December 24, 2021

    Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern medical devices are manufactured with integrated software and software in general has become [...]

  • Classifying Software as Medical Device in EU MDR

    March 9, 2021

    Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the scope of the EU MDR and IVDR.   This article seeks to [...]