How to CE Mark your Medical Devices and Avoid Problems!
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
Surgical Sutures 510(k)
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
Person Responsible for Regulatory Compliance, (PRRC)
The person responsible for regulatory compliance (PRRC) is not intended to take the place of a Europ...
Sampling Plan
The sampling criteria: The main sampling criteria are lot sizes, inspection levels, acceptable qua...
Medical Device Common Terms Definitions
Common Terms Used and their definitions are following Medical Device Medical device’ means any ins...