USA FDA Requirements
Should you wish to sell your product into the US market you will need to establish and maintain a quality system to ensure your device meets the applicable requirements and specifications.
The quality system for FDA is known as current good manufacturing practices and the requirements are documented under 21 CFR Part 820 of the Quality Systems Regulation.
Advena can offer regulatory consultation to guide you through the process whether that be:
FDA Pre-Submission meetings
Pre IDE meeting – Preparation and participation
Assistance with device listing and establishing registration
Pre IDE meeting – Preparation and participation
Assistance with device listing and establishing registration
