For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark.

Date : 3rd August 2017 to 4th August 2017

Place : United States, San diego

Website :https://www.eventbrite.com/e/how-to-prepare-a-510k-notification-and-a-technical-file-for-the-ce-mark-com-tickets-33510334312?aff=NDT

Contact Person:Paula Edwards

Description:

For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark.

For a new or modified medical device, product approvals are required prior to distribution. This course is intended to provide participants with a detailed list of documents and testing required for a 510(k) Notification submission to the US FDA and a Technical File for submission to a Notified Body for the CE Mark. will be held in San diego,United States on date 2017-08-04

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Deadline for abstracts/proposals : 1st August 2017

Keynote Speakers : James Barley Regulatory Affairs and Quality Assurance Consultant James Barley is a founder of Abrimed Consulting Services, a Medical Device Regulatory Affairs and Quality Assurance Consulting company. Mr. Barley graduated from Lowell Technological Institute with a degree in Engineering and later earned his Masters of Business Administration from Pepperdine University. During the last 20 plus years, Mr. Barley has been consulting for small and medium sized medical device companies. These servic

Conference Highlights :Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k) When to file for a new device, a change in the intended use or a change in the technology of a cleared device What is contained in a traditional, abbreviated and special 510(k) submission package What is substantial equivalence and what’s required to show substantial equivalence What’s required on the labeling and IFU Which performance tests should be conducted and how to pr

Venue :San Diego, CA, United States

Check the event website for more details.