Digital Health Technologies Regulatory Event

Time: 15:00 - 15:40

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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, industry partners from SMEs to major international digital & pharma companies, 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 45 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

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.