510(k) Submissions Workshop

February 25 – 26, 2013 — Sheraton Crystal City, Arlington, VA

Join quality and regulatory professionals at this interactive 510(k) workshop. Industry experts and key personnel from the FDA CDRH and CBER 510(k) staff inform you in detail on:

  • - Current FDA’s updates to the 510(k) process (Refuse to Accept Policy for 510(k)s)
  • - A step-by-step walkthrough of the 510(k) regulatory guidelines
  • - 510(k) practical steps & 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
  • - 510(k) post-clearance issues
  • - eCopy Program for Medical Device Submissions
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Sponsored by:

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

TESTIMONIALS

"Overall extremely helpful, well-organized. Appreciated hearing directly from the FDA staff about upcoming changes to the review process."

“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 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.