SHORT PREVIEW

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:

• When a Traditional 510(k) is the correct choice
• Traditional 510(k) key points
• Section and structure of the Premarket Notification

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.

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:

• Regulatory Affairs specialist
• Medical Affairs specialist
• Clinical Affair specialist
• R&D Engineers
• Quality Engineers
• Marketing

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:

• 90 days of 24/7 access to individual eLearning courses.
• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

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.