InnoScot Health is set to pool its expertise with others for a second time next month as part of a free webinar on how manufacturers can secure stateside medical device compliance

The formal NHS Scotland partner’s Head of Regulatory Affairs Elaine Gemmell will present at the webinar entitled 'FDA Regulations on Medical Devices: How to Penetrate the US Market', taking place on Wednesday 4 December from 10am.

Elaine – awarded the title of Honorary Professor of the School of Engineering and Physical Science at Heriot-Watt University last year – will be joined by Managing Director of Compliance Solutions, Edwin Lindsay, and Professor Marc Desmulliez, Manager of the Medical Device Manufacturing Centre (MDMC).

Run by MDMC and Scottish Enterprise, the deep dive session for companies aiming to navigate the specific processes of America’s Food and Drug Administration (FDA) follows a first held this year on the same subject in October.

It will be the second of three hosted on Microsoft Teams, ensuring flexibility for attendees.

Participants can now register interest for 4 December, with its focus on “what a manufacturer should consider when determining the strategy regarding entry into the US market for a new medical device,” and will be supplied with joining instructions.

MDMC will present an introduction to navigating medical device regulation as it stands in the UK and Europe, before Elaine and Edwin place their focus on the demands of the FDA.

Elaine said: “We are welcoming manufacturers of all experiences and sizes to these workshops with three taking place across a few months to ensure maximum choice for attendees.

“We expect the sessions to attract those who recognise that having the right knowledge when negotiating compliance with a new medical device in any given country is absolutely vital.

“My own focus will be on helping attendees understand the significant requirements around US regulatory processes if they are to negotiate this important market’s challenges while realising commercial ambitions.

“The workshops will therefore offer real world examples and unique insights, bringing to life what a manufacturer needs to know when considering their own strategy for achieving market penetration, and in turn boosting confidence when doing so.”