When you update your technical documentation, a great deal needs to be taken into consideration to comply with all the provisions of the Medical Device Regulation (MDR) and/or the In Vitro Diagnostic Regulation (IVDR). This applies not only when the device is placed on the market but also when there are modifications and updates.
You are best advised by an experienced partner who can guide you through the whole process. Our finely tuned team of experts will take all over all steps as well as the whole coordination. From contact with the authorities to necessary adaptations to your medical device technical documentation to translation into the requisite languages.
Everything under one roof. Everything from a single source. So that everything is just right.