The Medical Devices Regulation is identified as Regulation (EU) 2017/745.
The In Vitro Diagnostic Medical Devices Regulation is identified as Regulation (EU) 2017/746.
https://www.qadvis.com/wp-content/uploads/2022/10/qadvis_web-300x138_221001.png00Cecilia Emanuelssonhttps://www.qadvis.com/wp-content/uploads/2022/10/qadvis_web-300x138_221001.pngCecilia Emanuelsson2017-05-05 13:30:202017-05-05 13:30:20The new regulations on medical devices are now published in the Official Journal of the European Union
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.