Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
FDA - USA
The United States is the largest medical device market in the world. The US FDA regulations for device classification, pre-market approval, pre-marketing clearance, and registration are unique and can seem daunting. A well-planned and effectively executed device development and regulatory program will ensure a clear path to marketing in the US. Identifying the FDA product code and device classification set the foundation for the regulatory process. Depending on the classification, you may have to submit a Pre-Market Notification "510(k)” or a Pre-Market Approval “PMA” application. You will need a Quality Management System in line with FDA’s Quality System Regulation (QSR), and you will have to register your company as a “device establishment” and list your devices in FDA’s database. If you do not have a physical presence in the US, you will need to appoint a US Agent.
What will RegPro Medical Do?
We will help you plan and execute a strategy for classification, pre-market application, QMS enhancement, registration and listing. Depending on the classification and design of your device and your specific needs for support, RegPro Medical will work hand-in-hand with your team to achieve your goals for accessing the US Medical Device market.
Some of the services we are pleased to offer include:
· Device Classification assistance
· 513(g) Request for Information for classification
· Premarket notification 510(k)
· US Agent for foreign manufacturers
· Liaison with FDA
· Quality System enhancements to meet FDA’s QSR requirements.