Blog | Mysite

top of page

Search

Basic information about FDA’s Premarket Notification (510(k))

Basic information about FDA’s Premarket Notification (510(k))

Basic information about FDA’s Premarket Notification (510(k))

What is 510(k)? 510(k) is FDA`s premarket notification. FDA “clears” 510(k) submissions, authorizing a device to market in the US. That’s...

ikenreg

Aug 31, 20212 min read

Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices

Biological Evaluation of Medical Devices

Biological Evaluation is performed to measure the potential risk arising from the use of medical devices in Humans. It is a step by step...

ikenreg

Nov 23, 20202 min read

bottom of page