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.
You will leave the workshop empowered in preparing for your next 510(k) submissions.
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.
It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements.
In this 3 hr seminar, the speaker will walk you through how to prepare for and submit your next 510(k).
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