After an intensive audit by ISO and QMS auditors last
month, Monitex passed with few minor non-
conformances. Furthermore, another great news to
share with our European distributors and friends,
Monitex has successfully passed MDR documentation
review and approved 6 devices by our Euro
Representative, Obelis. After EUDAMED registration is
completed, Monitex devices can market and distribute
again in the territory of Europe.
Next, Monitex is going to submit 10 devices for MDR
documentation review in September. With previous
experience and guideline to follow, we are confident
that the amount of time needed to complete can be
faster.