Heriot-Watt and InnoScot Health partner up to deliver webinar on US medical device compliance
InnoScot Health and Heriot-Watt University are set to link up once again to deliver webinar learnings around successfully achieving Stateside medical device compliance.
Last year, the two organisations signed a five-year agreement which would continue to see Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC) collaborate with InnoScot Health to help bring new ideas and innovations from healthcare professionals to life.
Representing a fresh facet of that relationship, InnoScot Health’s Head of Regulatory Affairs Elaine Gemmell and Professor Marc Desmulliez, Manager of the MDMC will help to lead a free online webinar entitled FDA Regulations on Medical Devices: How to Penetrate the US Market which is taking place on Friday 24 November at 10am.
The workshop – run by MDMC and Scottish Enterprise – will be hosted on Microsoft Teams with a link provided to attendees following registration. Interested participants can register here to attend.
Interested parties can alternatively opt to take part in the same interactive workshop held on two other dates next year – Wednesday 24 January and Wednesday 21 February.
All three deep dive sessions will feature speakers Elaine – awarded the title of Honorary Professor of the School of Engineering and Physical Science at Heriot-Watt University earlier this year – and Marc, as well as Principal Consultant at Compliance Solutions (Lifesciences) Ltd, Edwin Lindsay.
The trio will be presenting an introduction to navigating medical device regulation as it stands in the UK and Europe, before shifting their focus to the demands of the United States’ Food and Drug Administration (FDA) where there are similarities but also significant differences for those looking to commercialise their products.
Elaine said: “We expect these workshops to be of interest to manufacturers of all experiences and sizes who fundamentally recognise that negotiating compliance with a new medical device in any given country is an absolute must if they are to achieve market penetration there
“Understanding the distinction between different territories’ regulatory processes is vital if they are to overcome challenges while opening up fresh opportunities for their commercial ambitions.”
She added: “Primarily, the sessions will aim to provide an overview of regulation in the US through real-life examples by first discussing what a manufacturer should consider when determining the strategy for introducing their new medical device into the UK market.
“This will then provide a counterpoint for explaining differing aspects in Stateside regulatory processes – some marked, some not dissimilar.
“Joining the workshops will allow you to better understand the basic definition of a medical device, its classification, and the resulting medical device regulations for which the device needs to comply to wherever it is being targeted.
“Before the pandemic, there was already movement towards increased governance around medical device innovation. Now, however, far-reaching new regulations are having a significant impact on everyone involved with medical devices, from their manufacture to their use.
“A strong understanding of regulatory compliance – both preparing for it and then navigating it – must therefore be intertwined with the development process early on when attempting to harness the true potential of new innovations.”
