RAPS workshop: the basics of 510(k) and working with the FDA

Published: 18-Oct-2017

Join RAPS for this two-day interactive workshop to learn from former US FDA regulatory authorities who will share their experience, tips and guidance to develop, prepare and submit a 510(k) application to FDA.

Hot off the press following the release of new guidelines ahead of the 8 November deadline, our trainers will provide you with all the insight you need for a successful submission.

By the end of the workshop, you 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 how to engage with FDA.

Note: each participant must bring his/her own laptop for use during the class. RAPS does not supply computer equipment for attendees

Event venue: Imperial Riding School Renaissance Vienna Hotel, Ungargasse 60, 1030 Vienna, Austria

Organiser: RAPS

Registration fees: RAPS members $1,150, non-members $1,250. Use code REC17 for $100 off.

Web: raps.org or click here to register for this course

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