510(k) Update – How to Format Succinct and Comprehensive 510(k)s – 3 Hours Virtual Seminar

MessageThis Webinar is over
Date Aug 22, 2018
Time (12:00 PM - 3:00 PM )
Cost 27400.00
Online
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality and to facilitate the review process in a streamlined manner.

Why You Should Attend:
A premarket notification [PMN or 510(k)] is the most common regulatory pathway to bring some medical devices into the US market.

The 510(k) application is submitted to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).

This seminar will discuss what to consider and how to prepare for the 510(k) submission package while ensuring 510(k) submission quality to prevent avoidable mistakes and delays and saving significant resources.

Who Should Attend:
  • Pharmaceutical Quality Departments
  • Medical Devices Quality Departments
  • Regulatory Affairs Departments
  • Pharmaceutical Compliance Departments
  • Medical Devices Compliance Departments
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs Departments
  • R&D Departments
  • Consultants
  • Contractors/Subcontractors
  • Everyone responsible or Interested in the 510(k) Matters


 

 


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