FDA Regulations on Medical Devices: How to Penetrate the US Market
InnoScot Health Head of Regulatory Affairs, Elaine Gemmell will participate in this webinar presented by Heriot-Watt Medical Devices Manufacturing Centre
Understanding of the medical device regulatory affairs in a given country is an absolute necessity for companies wishing to commercialise their products in a given country. Although there are many similarities in the regulation of medical devices in the UK, Europe and the USA, there are also some significant differences.
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The aim of the workshop is to provide an overview of medical device regulation in the USA (FDA) and, using real-life examples, discuss what a manufacturer should consider when determining the strategy regarding entry into the UK market for a new medical device.
A basic introduction as to what is a medical device is in the UK and the process needed to regulate it in the UK and Europe will be given first as a counterpoint to regulation in the USA.