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This workshop, hosted by Dr Peter Bowness, will focus on the requirements of risk management under the EU MDR 2017/745 and ISO 14971:2019, covering the 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 requirement for risk management for medical devices and how to interpret the ISO14971 standard as the methodology for compliance to these requirements.

Dr. Bowness was 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 ISO 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 animal 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).