EU 2017/745, the requirements for medical device clinical trials are part of Art. 62 through 82 and Annex XV. EU 2017/745 enforces all manufacturers must clinically evaluate a medical device before ...

A performance evaluation plan report is an important step for in vitro diagnostic devices that serves to meet IVDR EU 2017/746 general safety and performance requirements. Part A of Annex XIII ...

I3CGlobal assists Medical Device and Invitro Diagnostic device manufactures in preparing high-quality CER and PER with the assurance of Notified Body clearance. As a knowledge-driven and strategically ...

Please email us the device information and intended, we will be happy to assist you with additional infomation. I3CGlobal assists Medical Device and Invitro Diagnostic device manufactures in preparing ...