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FDA Regulations on Medical Devices How to Penetrate the US Market TEMPLATES Copy before use

FDA Regulations on Medical Devices: How to Penetrate the US Market


InnoScot Health and Heriot-Watt University are set to link up once again to deliver webinar learnings around successfully achieving Stateside medical device compliance

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.

A woman taking part in a webinar on her laptop.

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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


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