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510(k) The Process – Where Are We Today, An Update
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510(k) The Process – Where Are We Today, An Update

A quick review of the basics of a 510(k) submission and the process, then a focus on what is the most critical information that triggers questions today. What has been done in the past does not apply to FDA’s ever-changing landscape: new guidelines and new personnel and the contents and questions for a submission. Learn about the changes and what to address in your submission to help with successful clearance.

11/18/2014
When: 11/18/2014
8:00 AM
Where: Hilton Carillon Park
950 Lake Carillon Drive
Salon D
St. Petersburg, Florida  33716
United States
Presenter: Paul Dryden, President - ProMedic, Inc.
Contact: FMMC
(850) 270-3158


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510(k) The Process – Where Are We Today, An Update

A quick review of the basics of a 510(k) submission and the process, then a focus on what is the most critical information that triggers questions today.  What has been done in the past does not apply to FDA’s ever-changing landscape: new guidelines and new personnel and the contents and questions for a submission. Learn about the changes and what to address in your submission to help with successful clearance. 

 

Our Speaker 

Paul Dryden, President

ProMedic, Inc.

 

Mr. Dryden has been in the medical device industry since 1975. He was President of Dryden Corporation, Indianapolis, IN, an anesthesia / respiratory disposable manufacturer until it was sold to Louis Gibeck AB in 1988. He remained as President and then left to form ProMedic in 1992. Mr. Dryden has a BS from Purdue University, West Lafayette, IN, and an MBA from Butler University, Indianapolis, IN. He has been active in a number of medical device associations and is active in the ASTM / AAMI standards committees for anesthesia / respiratory devices. He currently serves on a number of company Boards and serves as a senior advisor for several clients.

 

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