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The Manchester Molecular Pathology Innovation Centre (MMPathIC), in collaboration with the Diagnostics and Technology Accelerator (DiTA) and NIHR Manchester Biomedical Research Center, is hosting a workshop on the 23 September at the Manchester Science Partnership Citylabs. This one-day event focusing on the regulatory requirements for IVDs and medical devices will be attended by NSF’s Robyn Meurant and Rachel Carmichael.
Understanding the regulatory route to market is key for successful commercialization. This workshop aims to give participants an overview of diagnostic test development, from the feasibility and patenting stages to the regulatory considerations one needs to be aware of if aiming for eventual uptake in the clinic.
Robyn Meurant, Executive Director, Regulatory Team, IVDs and Medical Devices, will start the workshop with an introduction to regulatory requirements for EU medical devices and IVDs. She will discuss critical aspects, including new requirements for clinical evidence, post market surveillance and economic operators (distributors, importers, etc.).
Rachel Carmichael, Executive Director, Pharmaceutical Services, will be discussing effective GxP data integrity governance, a matter of high importance for any device manufacturer.
This workshop is designed to be accessible to anyone, however places are limited – register now to secure your place.