Medical Technology Regulatory Event

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Online event

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This event is part of the Demystifying regulation and commercialisation mini-series, hosted through the Christabel Pankhurst Institute

About this event

Demystifying regulation and commercialisation mini-series:

This event is part of the Demystifying regulation and commercialisation mini-series, hosted through the Christabel Pankhurst Institute for Health Technology Research and Innovation. These events, taking place between June and October 2021, are organised by Advanced Materials in Medicine (AMM), Translation Manchester, Digital Futures, the University of Manchester Innovation Factory, and the Institute of Data Science and AI.

Medical Technology Regulatory Event

This event welcomes researchers, academics, clincians, ERDF SMEs and healthcare providers.

Agenda

13.00 - 13.05 The European Landscape

13.05 - 14.50 The EU regulatory pathway for medical devices

o Qualification

o Classification

o Conformity assessment routes

o Main stakeholders

o Quality assurance requirements

o Product development activities (example of materials and digital health solutions)

o Differences with pharma and IVD

14.50 - 14.55 Comparison with the US

14.55 - 15.00 Q&A

Kyun Thibaut Bio

As a hands-on trilingual Mechanical Engineer with a passion for Life Sciences and Medical Devices, Kyun Thibaut has had the opportunity to work in various companies belonging to the most high-tech industries in the world. His career has brought him to various positions such as R&D Engineer, Systems Engineer, Project Manager, Product Development Manager, Program Manager.

In 2016, driven by his passion for MedTech, he let go to his entrepreneurial spirit and launched COVARTIM, a Belgian engineering company 100% focused on Medical Devices.

To book a 1-2-1 with Kyun on 9th September 2021, please email pankhurst@manchester.ac.uk.

Research & Innovation (R&I Health Accelerator) Programme:

Not yet Enrolled in the Research and Innovation Health Accelerator Programme?

Are you an SME looking to collaborate with Greater Manchester’s research and innovation institutions? Would you like access to expertise and support for your business?

Contact Vicky.Bertenshaw@healthinnovationmanchester.com to discuss the programme further and to see if your company is eligible to enrol.

The project invites SMEs to collaborate with Greater Manchester’s research and innovation institutions to accelerate development and improve commercialisation of innovative healthcare products and services within life sciences.

SMEs will be able to access expertise and support including information about navigating the health and care system, developing value propositions, ethics & regulatory advice and access to university-wide expertise.

There will also be opportunities to build lasting research collaborations between SMEs, researchers, Greater Manchester universities, NHS organisations and the broader health innovation community. These collaborations will be used to share knowledge, address the barriers to adoption and co-develop proposals for research and development projects.

The programme, which is open now and will run until June 2023, will engage with SMEs across a range of health and care products and services, but with a particular focus on AI & digital technologies, medical devices, biosensors, genomics & precision medicine, diagnostics, biopharmaceuticals, and applications of advanced materials.

Eligible SMEs will be able to access two levels of support, both with a menu of support activities that can be mixed and matched to meet their specific needs.


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Date and time

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Online event

Organiser The Christabel Pankhurst Institute

Organiser of Medical Technology Regulatory Event

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