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AEMPS Applies for NB Designation
According to the MDR requirements, Notified Bodies (NB) should be designated to maintain operations connected with the registration process and perform other supervisory actions. In the course of these medical device...
EMA Releases Guidances Addressing Drug Shortages
On Friday, the European Medicines Agency (EMA) released two guidance documents addressing issues surrounding drug shortages in the EU, and how to manage drug shortages publicly. These documents were created by a task...
An Overview Of Medical Device Regulations In Finland
MEDICAL DEVICE REGULATIONS IN FINLAND   Medical device regulations tend to vary substantially from region to region as virtually every country has its own set of rules that manufacturers must comply with in order to...