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RAPS workshop: The Basics of 510(k) and Working with the FDA

RAPS workshop: The Basics of 510(k) and Working with the FDA

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If your company markets medical devices into the USA, you need to be aware of the 510(k)-authorisation requirement, administered by FDA, to ensure that your medical device is approved for use in the global marketplace.

This two-day interactive workshop, hosted by RAPS, is led by a former FDA Director and supported by other industry leading experts within the 510(k) field who will provide you with all the necessary 510(k) regulatory requirements and dissect every aspect of the submission process to help you to increase your understanding of it. 

Providing you with this face to face encounter with those who developed and ran the regulatory programme will not only give you access to direct contact with the experts and the opportunity to address your specific questions, scenarios, experiences but also provide you with specialist insight that will enable you to be more successful in preparing 510(k) submissions and in managing the review process.

By the end of the workshop, you will have a thorough understanding of the regulatory framework behind FDA's classiï¬Âcation of medical devices; practical guidance on how to develop, prepare and submit a 510(k) to FDA; and insight into 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



Early bird offer available before 26th March 2018: RAPS Members: $1,050, Non-members: $1,150. 27th March and after: RAPS members: $1,150, Non-members: $1,250



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