Dr. STEPHEN SMITH

Stephen started his journey in Quality Assurance and Regulatory Affairs in Medical Devices in 1999. Starting as an internal auditor he went through the ranks to being a QA/RA Director leading teams of up to 25 internationally. Over this time he has seen vast changes in technology, regulation, perception and practice. He has gained experience in IVD's and devices ranging from device disinfection solutions/systems to surgical robots and implemented Quality Systems in several organisations. He has experience in placing devices in the EU, US, Australia, NZ, Singapore and many other countries and been audited more times than he cares to remember. 


He says 'Working largely with R & D, I have always been questioned 'why?' by scientists and engineers, why do I need to dot that 'i', why do I need to cross that 't'? This led to him questioning the effectiveness of quality regulation and completing his PhD on that very question. The result is that he thinks outside of the box to find practical solutions to compliance that are risk-based, pragmatic and more effective. With more than 25 years in the industry both in start-ups and multinationals he has seen things done well, not so well as well making his own mistakes along the way - but learning from each one. He also knows the early warning signs that lead to failure, something that only comes from experience. 


As well as a PhD in medical Device Quality Management, Stephen also has a Masters degree in Medical Diagnostics, another Masters in Physical Geography, and a Bachelors degree. He is a Fellow of the Chartered Quality Institute (CQI) - the highest grade of membership awarded for substantial achievement/contribution to the Quality profession, a voluntary member of CQI's Content Advisory Panel, has lectured on QA/RA topics at postgraduate level, is a member of TOPRA, a six sigma green belt, and a trained lead auditor. 


Born in Glasgow and growing up in New Zealand he is based near Cambridge UK but spends his time between UK and New Zealand visiting countries and clients in between.