Food and Drug Administration (FDA) Regulations on Medical Devices: How to Penetrate the US Market
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Posted: 11-November-2025
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 US market for a new medical device
InnoScot Health's Head of Regulatory Affairs, Elaine Gemmell will give an overview of FDA regulation of medical devices during the workshop.
It will also include a basic introduction of what a medical device is in the UK and the process required to regulate it in the UK and Europe will be given as a counterpoint to regulation in the USA.
Find out more
This free course will run in a hybrid form on Friday 28 November. Online will be through Microsoft Teams, while in-person will run at Heriot-Watt University, Edinburgh EH14 4AS (room: EMG.83). Please, when registering, specify the preferred form of attendance.
For people attending in person, a lab tour of the Medical Device Manufacturing Centre facilities will also be provided at the end of the course.
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