Street: 1st Floor, Building 1, 3 Smithy Wood Drive, Smithy Wood Business Park
This free breakfast seminar will focus on how to access the US market using the 510(k) process - the 510(k) process is used when a similar product, which has been previously approved, already exists in the US marketplace; allowing the applicant to build on evidence already accepted by US authorities.
The seminar will be run by Colin Rylett, Managing Director of Mediqol Ltd, a leading consultancy in regulatory pathways and product approvals. The seminar will cover:
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What are US FDA classes I, II, and III products?
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510(k) determination; new and substantially modified applications and the benefit of the 513(g)
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What are the three types of 510(k)s, which is justified?
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The importance of the ‘Intended Use’ statement?
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How to locate predicate devices
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Important considerations in choosing the predicate device for the 510(k)
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Risk analysis including software considerations and reporting
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Additional data requirements
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The 510(k) and DHF files.
If you would like to book your place on this free seminar, please contact Nikola Alevizos at n.alevizos@medilink.co.uk
Email: n.alevizos@medilink.co.uk