On 21 May 2024, the EU Council approved the AI Act — a major of regulatory law that defines comprehensive rules on artificial intelligence and relevant technologies. The AI Act has a risk-based approach, ensuring the transparency, reliability and accountability of the technology, bringing the sector-specific requirements. Considering that the softwares as medical devices are becoming […]

FDA just published an amendment related to the Quality Management System Regulation (QMSR), 21 Code of Federal Regulation Part 820, which will replace the current regulation (QSR). There will be an impact for companies that are planning to export to the USA and those already present on the U.S. market, we present it in free on-line […]

  As having the new regulations, supplier quality management has come to be seen as the most important subheading of the Quality Management System and functions as a cyclical process linked to other parts of the Quality Management System . The new requirements have made the supplier management process and supplier evaluations much more […]

Softwares offer rich solutions for diagnosis, treatment and improving quality of life. They have entered our lives through many areas, such as from archiving patient records to sports and wellness apps, from diagnostic and imaging devices to clinical studies and education… As we all know, medical device legislation is subject to different regulations in different […]