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 […]
We guided one of our startup clients through the process of achieving ISO 13485 certification
We are particularly focused and proud to sponsor initiatives in the technical / scientific field.
2020 has been a challenging year for all of us, but we are ready to continue to help to create an healthier word!