Led by Will Burton, this session will cover the following topics:
1. Why regulate?
- What are the regulations?
- What is the link between Regulations and Quality.... Do you really need a QMS?
- How do you work out which regulation(s) to follow? Introducing
- Intended purpose / Intended use
- Regulatory strategy - what is it, why do you need it and which jurisdiction first?
2. Common MedTech / Pharma companies' (not just spinouts') failures
This presentation will close with a Q&A section, as always.
Will Burton 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 Representative (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 the Medicines and Healthcare products Regulatory agency, 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). Hence, Will has very extensive auditing and quality systems experience and was also closely involved in the selection, training and monitoring of UK Notified Bodies. He was 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).
*These workshops and talks are designed for researchers, academics and aspiring entrepeneurs interested in therapeutics, medical devices and/or in vitro diagnostics development. We aim to support your project from concept and laboratory to clinic.
This SPARK The Midlands event 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 of Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.
For any enquiries, please email us at spark-uk@aston.ac.uk or visit www.sparkthemidlands.co.uk/contact
