InnoScot Health to offer personalised guidance for regulatory approval
InnoScot Health will deliver a further three days of free personalised guidance for those looking to achieve regulatory approval for a medical device or in vitro diagnostics (IVD) in the UK and US.
The second call – following the first in December last year – is being offered by Heriot-Watt University’s Medical Device Manufacturing Centre (MDMC), in conjunction with Scottish Enterprise and will be delivered by InnoScot Health.
Interested Scottish organisations must complete the application form before midnight on Monday 12 February. Any questions regarding the service or application process should be directed to mdmc@hw.ac.uk
InnoScot Health’s head of regulatory affairs, Elaine Gemmell said: “Bespoke advice for those seeking to achieve regulatory compliance in the UK, Europe, and US is vital given the differences in approach required to successfully navigate these key territories.
“For those who might have missed out the first time, this second call represents a great opportunity to receive that important know-how free thanks to MDMC, in turn aiding the navigation of complex processes and helping Scottish organisations to overcome significant barriers.”
Gemmell – awarded the title of honorary professor of the School of Engineering and Physical Science at Heriot-Watt University last year – will also join Edwin Lindsay, principal consultant at Compliance Solutions (Lifesciences), and Professor Marc Desmulliez, manager of the MDMC, for a free online webinar next month.
Entitled FDA Regulations on Medical Devices: How to Penetrate the US Market, this will take place on Wednesday 21 February and is the last of three similar sessions held over recent months.
The workshop – run by MDMC and Scottish Enterprise – will be hosted on Microsoft Teams with a link provided to attendees following registration.
Gemmell, Lindsay, and Desmulliez 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.