FDA 510(k) Expert for Vital Signs Monitoring Device

I'm seeking an experienced professional to assist with the submission preparation for a 510(k) application for a Class-2 monitoring medical device, specifically designed to monitor vital signs. The device is intended for a mobile application, but we also need to set up an AWS server to upload and download data. our gateway is the mobile application. Key Responsibilities: - Prepare and compile all necessary documentation for FDA submission - Ensure all materials meet regulatory standards - Provide guidance on best practices for successful submission Ideal Candidate: - Proven experience with FDA 510(k) submissions, specifically for Class-2 monitoring devices - Strong understanding of regulations surrounding medical devices and mobile app integration - Excellent technical documentation skills - Prior experience with vital signs monitoring devices is a plus. Your expertise will be critical to ensuring our compliance and successful submission preparation.