Shining A Light on MDR Notified Body Standard Fees
The EU Medical Device Regulations (MDR) has been a looming, dark cloud of change for Medical Device Manufacturers. Whether the discussion is focused on the new…
The EU Medical Device Regulations (MDR) has been a looming, dark cloud of change for Medical Device Manufacturers. Whether the discussion is focused on the new…
What Do Your Annual Internal Audit and Annual Physical Have in Common? They both roll around once a year, and both are typically dreaded. Your annual…
What is a Medical Device Report? Medical Device Reports (MDRs) are publicly accessible documents resulting from an event that manufacturers or importers become aware of and…
On October 21, 2022, the Medicines & Healthcare Products Regulatory Agency (MHRA) announced that they are adding a twelve-month extension to the current standstill period on…