Seminar - Online
FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts. Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together for your successful submission to the FDA compliant with the FDA’s eCopy and RTA policy. This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. This presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.
Monday, May 18, 2015 (13:00 - 14:00)
Mississauga, Ontario 44813, Canada
Phone: 4169154458
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