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...
Information required for MHRA Registration Registration
The following are the information requested by MHRA Registration of Medical Devices. Manufact...
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...
What is Literature Search
All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDD...
Surgical Sutures 510(k)
* In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen...