Setting the bar high! We are proud to announce that NewCompliance has received the ISO 13485:2016 certificate.
Our work towards the ISO 13485:2016 certification with Kiwa demonstrates our commitment to providing high-quality and consistent solutions to our clients. In order to receive this certificate, organizations must be able to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. With this new achievement, we are also preparing ourselves for the requirements of the new European Medical Device Regulation (MDR).