SSI/Medtech US Regulatory Submission "Best Practices"

Robert has over 25 years of medical device RA/QA experience and has significant RA experience with successful 510 (k) & PMA submissions, FDA interactions, QMS experience with over 10 years of leadership insight. Join us for an interesting conversation on the regulatory submission pathway, the differences between the 510 (k) and PMA processes, key items to consider when interacting with the FDA and governing bodies as well as some insights on leadership and proactivity.