A Global Approach to Clinical Evidence for Medical Devices. 13 June

June 13, 2019


Arthur Brandwood and Heyam Kalla are presenting this one day workshop at ARCS.

Regulators the world over are raising the bar for medical device compliance, and no more so than in clinical evidence requirements. Every device and IVD no matter its risk class must have formal clinical evidence showing real world safety and performance. New guidances in Europe, Australia and China specifically require direct clinical trials as a default position for high risk devices. More and more US FDA 510(k) submissions must include direct clinical testing data.

This workshop looks at the requirements around the world and how to put it all together. At the end of the workshop you will have a clear understanding of the key global requirements and how to construct Clinical Evidence Dossiers to support global regulatory filings and ongoing compliance.

Find out details and register here

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Date and Time

June 13, 2019
9:00 am - 5:00 pm


ARCS Australia North Sydney

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