510(k) Submissions Workshop

October 15 – 16, 2012 — Sheraton Crystal City, Arlington, VA

For updated information on the next 510(k) Submissions Workshop:
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This interactive 510(k) workshop, taught by industry experts and key personnel from the FDA CDRH    510(k) staff, informs you in detail on FDA’s updates to the 510(k) process, leads participants step by step through the 510(k) regulatory guidelines, 510(k) practical steps, and 510(k) strategic considerations for determining a product's regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with FDA during the 510(k) review process, and dealing with 510(k) post-clearance issues.

Please contact skinchen@advamed.org for Group Discounts
(discount does not apply to EGCC, Government, or Non-Profit Organizations)

Sponsored by:

TESTIMONIALS

“I had no prior experience with 510(k) submissions. The MTLI course enabled me to learn the mechanics of such type of submissions in a small and informal setting. It was easy to talk to the instructors and the other experts from the related fields.”

“The 510(k) seminar was very professional and the presenters were knowledgeable. The panel provided great support and comments.”

"The speakers and information presented were excellent. I attended a 3 day conference on various FDA topics 2 weeks ago that was less than average compared to this event."

"I enjoyed the quizzes and interactive exercises. It was a great way to try and apply some of what we learned. Overall, it was a good experience and I look forward to being able to attend other MTLI courses in person or online."

"I am very new to regulatory affairs, having transferred from the quality system world. This seminar was really informative and helped gain a better understanding of the 510(k) process."

This workshop is pre-approved by RAPS as eligible for up to 12 credits towards a participants RAC re-certification upon full completion.

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