The website of the Clinical Services Journal

Free MDMC guidance on achieving regulatory success in UK and US

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 short 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.” 

Elaine – 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) Ltd, and Professor Marc Desmulliez, Manager of the MDMC, for a free online webinar next month. 

Titled 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.  

  • Register to attend 

The trio of Elaine, Edwin, and Marc 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. 

Upcoming Events

Advancing Ultrasound Probe Decontamination Study Day

Horizon Leeds, 2 Kendall Street #3rd Floor Leeds LS10 1JR
12th March 2024

Webinar: How to be Compliant and Sustainable In Healthcare

ONLINE
19th March 2024 & 21st March 2024 10 am CET time o

POCT Innovators: The Power to Disrupt Series

Cloth Hall Court, Leeds. UK
20 March, 2024

Central Sterilising Club - Annual Scientific Meeting 2024

Crowne Plaza at Gerrard’s Cross
15th April 2024 – 16th April 2024

DECON UK 2024

National Conference Centre, Birmingham
17th April 2024

Infection Prevention & Control

National Conference Centre, Birmingham
23rd - 24th April 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

Upcoming Events

Advancing Ultrasound Probe Decontamination Study Day

Horizon Leeds, 2 Kendall Street #3rd Floor Leeds LS10 1JR
12th March 2024

Webinar: How to be Compliant and Sustainable In Healthcare

ONLINE
19th March 2024 & 21st March 2024 10 am CET time o

POCT Innovators: The Power to Disrupt Series

Cloth Hall Court, Leeds. UK
20 March, 2024

Central Sterilising Club - Annual Scientific Meeting 2024

Crowne Plaza at Gerrard’s Cross
15th April 2024 – 16th April 2024

DECON UK 2024

National Conference Centre, Birmingham
17th April 2024

Infection Prevention & Control

National Conference Centre, Birmingham
23rd - 24th April 2024

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

Step Communications Ltd, Step House, North Farm Road, Tunbridge Wells, Kent TN2 3DR
Tel: 01892 779999
www.step-communications.com
© 2024 Step Communications Ltd. Registered in England. Registration Number 3893025