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 in June and July 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.

Also tieing into the Manchester Connected Health Ecosystem, the event is aimed at world leading academic expertise, businesses, Health and Social Care professionals across the NHS, Public Health and local government, and patient and service user representatives.

Understanding Medical Device Regulations & Design Control

We are proud to announce Richard from QMS Consultancy Ltd is hosting a Medical Device Regulatory Clinic, as part of the wider Demystifying Regulations & Health Economics Mini-Series. Richard will be sharing his experience by defining what it takes to gain Regulatory Compliance for MD’s, IVD’s and Stand-Alone MD Software (SaMD).

Questions answered during the Regulatory Clinic include:

- Is my innovation a Medical Device?

- How do I classify a MD, IVD, SaMD, Digital Technology, Telemedicine etc?

- What is a typical roadmap to Regulatory Compliance?

- What is ISO 13485 (software) and how do I get certified?

- What is meant by Design Control and how does this relate to TRL’s (Technology Readiness Levels)?

Following a 40 minute presentation Richard will throw questions out to the floor. Those wishing to know more and to gain a 1-2-1 assessment of their specific device or technology can book an appointment after the event by emailing 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.

Relevant funding opportunity: Access to Expertise award (Translation Manchester)

The timely Access to Expertise award from Translation Manchester enables researchers to access appropriate expertise to help unblock specific bottlenecks associated with translational research. Researchers can apply for up to £25,000 to access technical expertise such as (but not limited to): bioinformatics, biostatistics, physicians and nurses time, software, app design or programming expertise and regulatory advice. Call will open in the summer with projects expected to start in November. Information on previous calls are available on this page of the Translation Manchester website.