What’s an EU Authorized Representative?
August 10, 2023
RQMIS is an EU Authorized Representative. What does that mean for you?
Showing 21 to 25 of 84
August 10, 2023
RQMIS is an EU Authorized Representative. What does that mean for you?
August 8, 2023
Software as a Medical Device (SaMD) has transformed healthcare, but complying with the intricate regulations in the EU and UK can be challenging.
August 3, 2023
The revised guidance includes requirements for how FDA provides feedback through the Q-Sub process in line with goals outlined in MDUFA V.
August 1, 2023
Now, pre-submissions can be submitted using “PreSTAR”: an interactive, macro-enabled PDF template. At RQMIS, we’ve already begun appreciating the simplicity that this new format offers – fields are dynamically updated and all supporting documents and test reports can now be maintained from one place.
July 25, 2023
The EU Authorized Representative plays a key role in supporting manufacturers in achieving QMS compliance.