Скачать с ютуб Webinar for Special 510(k) Submissions в хорошем качестве

Webinar for Special 510(k) Submissions

This webinar discusses what exactly a Special 510(k) is as well as to how your design plan should be different for a Special 510(k) submission. Other questions to be answered are: Can you change your indications for use from your predicate device? Do you have to utilize a predicate device? What does the Special 510(k) RTA checklist look like? Can your first 510(k) be a special 510(k)? Do technology changes from a predicate device affect Special 510(k) status? Can the FDA convert my Special 510(k) Submission into a Traditional 510(k)? Do you need assistance with a new or current 510(k) Submission? To learn more about the process or to speak with us about our consultation services please visit it us at www.medicaldeviceacademy.com or email at [email protected] See our other available webinars at http://medicaldeviceacademy.com/webin...