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For this SPARK Studio, Mark Grumbridge, the MHRA Head of Clinical Investigations, will be talking us the through what to expect when applying for authorisation to conduct a clinical investigation of a medical device in the UK. 

Mark is an NMC registered nurse, first qualifying for this position in 1991. Since March 2022 he has been the Head of Clinical Investigations at MHRA having previously held the role of Senior Clinical Advisor and has worked at the MHRA since January 2012. 

He is also a committee member for ISO 14155 (Clinical Investigation of Medical Devices) representing MHRA and the UK. 

His role at the MHRA involves managing all aspects of clinical investigations including: 

• Provision of advice and support for applicants 

• Sourcing expertise 

• Reviewing applications for clinical investigations 

• Managing a team of regulatory handlers 

• Implementing regulation 

Mark has an NHS career spanning over 35 years and has worked in many clinical areas including Haematology, Acute Medicine, Senior Management and Project Management. 

This SPARK The Midlands is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.