US FDA Medical Device Classification System: Your Guide
The FDA classifies medical devices into three categories based on associated risk level. Each device class requires a different level of regulatory control. These guidelines are in place to ensure the safety and effectiveness of the device. Hence, manufacturers...
FDA 510(k) Submission for Active Devices: Need & Requirement
Owing to their reliance on external energy sources, active medical devices pose moderate risk to the patients and users. Hence, they have to be regulated accordingly. They fall under the purview of FDA 510(k). Manufacturers will have to demonstrate their device is...
Best US FDA 510(k) Consultant Service for Medical Devices
Are you a medical device manufacturer seeking FDA 510(k) clearance? Well, you have landed in the right place. We are a renowned US FDA 510(k) consultant. Our team will help you navigate the FDA’s regulatory requirements with ease. Our aim is to reduce the time to...