510(k) Premarket Notification Workshop – Bringing Medical Devices to the U.S. Market
About This Course
Learn 510(k) basics, including how to construct a complete 510(k) submission direct from the perspective a former FDA reviewer. NSF’s 510(k) premarket training also provides insight on how to communicate effectively with FDA via the pre-submission process and takes you a step further on what to do when you have a cleared 510(k) device that needs modification, while considering risk management principles.
Who Should Attend
This course is vital for any medical device quality professional including quality directors, manager, engineers and auditors responsible for implementing a quality management system in accordance with ISO 13485:2016 or planning to undergo an MDSAP audit.