US medical device regulations and 510(k) training, 13-14 November 2017 in Vienna, Austria.


The GMDN Agency is teaming up with RAPS to promote best practice in medical device regulation. RAPS is running a program on understanding US medical device regulations and preparing a successful 510(k) submission. By the end of the workshop, attendees will have a thorough understanding of the regulatory framework behind FDA's classification of medical devices; practical guidance on how to develop, prepare and submit a 510(k); and tips on how to engage with the FDA from two senior ex-FDA experts. To get more details and reserve a seat go to http://raps.org/510k-Vienna/. Places are limited to 30 with early bird offers available before 14th October 2017.