Webinar – FDA Registration – Traditional 510(k) – Medical Device Regulatory
Download the course BrochureAvailability: Right Now (Recorded Presentation)Duration: 45 min. (the average time to complete the training program).
This webinar course will describe how to manage a new Traditional 510 (k), providing description of the details to include in each Section of the application. The specific points that will be treated in the webinar are:
A complete 510(k) Template will be provided within the training course. This will be highly beneficial to start immediately implement the things learned, get a comprensive understanding of the documentation requirement and begin drafting your next submission.
|Why You Should Attend:
United States is the most important market in the world for the use of Medical Devices. A clear understanding of how to create an FDA application is therefore necessary to evaluate the possibility of marketing products on the US market. This webinar course will provide a comprehensive overview and guidance to how a Traditional 510(k) must be prepared, what are the information FDA would like to find in this type of submission, and relevant guidances to follow.
Who Will Benefit:
Certification Requirements: Students must view the entire 510(k) Training program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.
Online Training Programs Includes:
Course Presented and Commented by:
Giovanni De Paolini is a Pharmaceutical Chemist, graduated at Università di Parma. He started working in Medical Device regulatory field in 2006 and has always supported Medical Device companies in obtaining CE and International approvals. He assists companies during inspection audits and in the preparation of technical documentation, in product concept and development, in Due Diligences and in any case of communication with Competent Authorities.