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This session will cover:
Why you should regulate
Common MedTech / Pharma companies’ (not just spinouts’) failures
Will Burton will lead this SPARK Studio. He is a seasoned Pharmacist, Medicinal Product Qualified Person, Medical Device Expert, and registered international lead assessor. He is the founding director of Russell Square Quality Representatives (RSQR) Ltd, a company providing a range of Regulatory and Quality consultancy, training and troubleshooting services to the international medical device, pharmaceutical and biotechnology sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents and formed the foundation for ISO 13485 (Quality Management System (QMS) for Medical Devices). Will has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He was also instrumental in the development of the original EU Medical Device Directive (93/42/EEC, 1993), which still forms the basis of the current EU Medical Device Regulation (EU 2017/745).