Existing Device Web-based Seminars

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Design Control for Medical Devices - Webinar By GlobalCompliancePanel ...duction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls,  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ... * Deciding When to Submit a 510(k) for a Change to an Existing Device * What happens if FDA requires additional information and data and your responsibilities Interactive Q&A, Wrap-Up and Adjourn * Q&A with all attendees * Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry * Discussion Points: some of  more...