Favorite books |
A device's FDA 510k filing contains enough details to show that it is at least as safe and effective as a comparable non-medical device. We are FDA 510k Consultants and offer professional guidance, analysis of predictive devices, identification of product codes and regulation numbers, preparation, identification of testing requirements and standards, US Agent service, Q-Submission, FDA review response, and update as part of our services. Visit our website for more information on the FDA 510k Certification.
https://www.i3cglobal.com/fda-510k/ |