Performance Tests – Bench, Animal, Clinical
Most 510(k) submissions will include some type of performance data. The extent of performance data w...
FDA 513g Guidance
Medical Device manufacturers often file a FDA 513g request to establish if the requirements apply to...
FDA 510k Biocompatibility Assessment
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...
How To Register A Product With The FDA
FDA Registration for New Drug is mandatory if you want to sell OTC and over the counter drug product...
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 FDA 510k
* 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...