Licenses
...we take care of the management!
AEMPS Manufacturing / Import License Processing
We manage all the procedures!
Documentation
We manage and process all necessary information before the AEMPS.
Inspection
We help you pass the inspection successfully and with full confidence.
Resolution
We resolve any deviations detected during the process.
The prior operating license is a mandatory requirement for Spanish companies wishing to manufacture or import any medical device or IVD in the European Union. It is a complex procedure that must be approved by the AEMPS (Spanish Agency for Medicines and Medical Devices).
At MeDev Consulting we manage and process all necessary information, help you pass the inspection and resolve any deviations detected.