Led by Dr Peter Bowness, a decision maker and regulatory and technical specialist for the EU Notified body and UK Approved Body, BSI, where he led the biologics technical team. At BSI, Dr Bowness was the subject matter expert on risk management for medical devices under ISO 14971, information to be provided to users under IS0 20417 (replacing EN 1041), graphical symbols for medical devices under ISO 15223 and procedure packs under Directive Article 12 and Regulation Article 22 and wrote procedures and guidance on the interface between risk management, clinical evidence, PMS/PMCF and information provided to users. Dr Bowness worked in industry for 8 years, running stability and drug release testing for recombinant antibody therapeutics in a GMP testing laboratory and in medical device R&D, leading projects to develop tissue collagen implants for guided tissue regeneration in a range of clinical applications. In addition, Dr Bowness is chair of the British Standards Institution technical committee CH/210/WG3 and Member ISO/TC/210 (Quality management and corresponding general aspects for Medical Devices), Member (CH/210/04 (Risk analysis for Medical Devices) and Member (CH/194 (Biological Evaluation of Medical Devices).
This workshop will focus on the requirements of risk management under EU MDR 2017/746 and ISO 14971:2019, covering foundational concepts and risk processes to be applied, including the interface of risk management with other mandated requirements in the regulations. Delegates will learn the regulatory and legal requirements for risk management for medical devices and how to interpret the ISK 14971 standard as the methodology for compliance of these requirements.
*These workshops and talks are designed for researchers, academics and aspiring entrepeneurs interested in therapeutics, medical devices and/or 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
