ISO 13485:2016 standard

We are pleased to announce, we have recently been certified to the ISO 13485:2016 standard, an internationally recognized quality system standard, signifying the Quality System at Medifactia AB, which ensures processes are in place to address quality system aspects related to medical devices.

This ISO 13485:2016 upgrade shows Medifactia´s commitment to providing agreed levels of quality care and patient safety to the manufacturing of Transit-Pellets radiopaque markers, and the same high levels of conduct in our business practices. With this new achievement, we are also preparing ourselves for the requirements of the new European Medical Device Regulation (MDR) 2017/745.