Device Changes, FDA Changes, and the 510(k)-2019

Overview:Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based?
Areas Covered in the Session:Is the process "risk based"?K-97-1 and the FDA's "Decision Tree"Documenting the process / rationaleResolving a "wrong decision"
Who Will Benefit:Senior Management, Project Leaders, Internal / External ConsultantsRegulatory AffairsQuality Systems Personnel / QAER&D and Engineering Staff
Speaker Profile:John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: compliance4all14@gmail.com