Medical Device 2012 - 2-day In-person Seminar: How to Format Succinct and Comprehensive 510(k)s and PMAs

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 discussed in recent guidance documents including those (e.g., clinical trials) pertaining to premarket approval (PMA) so that the review process can be facilitated in a proactive and streamlined manner.

This seminar will discuss the 510(k) and PMA submissions and will walk you through how to format a succinct and comprehensive 510(k) and premarket approval (PMA) application to increase submission quality and to proactively facilitate the review process in a streamlined manner.

This seminar will discuss:
- The recent changes in the 510(k) program and guidance documents relating to both 510(k)s and PMAs.
- How to identify and assess the regulatory requirements.
- How to meet the regulatory requirements in a systematic, integrative manner.
- How to increase a 510(k) and PMA submission quality.
- How to format succinct and comprehensive 510(k) and PMA submissions.