Performance Tests – Bench, Animal, Clinical
Most 510(k) submissions will include some type of performance data. The extent of performance data w...
Section 513(g)
Section 513(g) of the FDA One of the difficulties that medical device manufacturers encounter is dec...
FDA 510k Biocompatibility Assessment
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
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...