Your One-Stop Source for Satisfying FDA Requirements
Medical Device Consultants, Inc. (MDCI) has a proven record of success using a comprehensive project approach to safety syringe 510k submissions. MDCI’s expert consultants have the regulatory knowledge and experience you need, and most importantly, MDCI can manage the entire process, from start to finish, freeing up your valuable time and resources.

The MDCI Safety Syringe 510k Submission Package includes:

Biocompatibility & Mechanical Device Testing MDCI can save you the time and anguish of identifying test laboratories to conduct your biocompatibility testing, latex testing, and functional testing of your device and the predicate device. We will identify the testing required for these products in general, your product in particular and determine testing costs. MDCI will oversee the entire testing process, regularly informing you of its progress, and interfacing with the test laboratories on issues that may arise during testing.

Simulated Use Testing MDCI will take the mystery and misery out of conducting the recommended simulated use testing of your product. The MDCI Clinical Services department, along with our professional network, will design the product-specific simulated use testing as described in FDA Guidance for Devices with Sharps Injury Prevention Features. We will enroll product evaluators who are representative of your final user population and who will evaluate all aspects of your product from the packaging to the final injection and product disposal. MDCI will analyze the collected data and provide you with a formal study report, suitable for inclusion in the 510k premarket notification.

510(k) Preparation and Submission Finally, using the documentation you have provided about your product, along with the results of the device and simulated use testing, MDCI will develop the 510k premarket notification to fulfill FDA requirements for clearance. MDCI will submit the documentation to FDA on your behalf and act as the Agency's primary contact during the review process. Or, if you prefer, MDCI will provide you with the required number of document copies, assembled, and ready for your submission.

Speak with a Consultant

Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.