Practical Medical Device QA and RA solutions when you need it
About us...
Practical QA/RA brings together 25 years of expertise in Medical Device Quality Assurance and Regulatory Affairs, complemented by accessible clinical insights. This unique combination ensures that the voice of the customer is to device development and maintained throughout the product life cycle. Our commitment is to quality and compliance while prioritising user needs.
Dr. STEPHEN SMITH
Lead Consultant, Co-Founder
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.
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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.
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View Stephen's Linkedin profile here.
Dr. MARIA VELLA
Co-Founder and Clinical advisor
Maria is a Consultant Obstetrician and Gynaecologist and brings a necessary clinical eye to the table. In her 25 years clinical experience she has seen great medical devices that she has used repeatedly and ones which she has tried once and never used again - whilst also telling colleagues of the experience.
Maria knows what clinicians want and what they don't, and most importantly knows what may present a clinical risk which many companies fail to consider, particularly in early stages.
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Maria completed a two-year research fellowship in Urogynaecology with Professor Linda Cardozo at Kings College Hospital, London, followed by a three-year subspecialty program in urogynaecology. She has a passion for research and has been involved in the publication of many papers which are widely cited. She is often invited to peer reviews has presented at national and international meetings and written a number of book chapters.
Maria received recognition for best free paper in 2006 by the International Urogynaecological
Association, and again in 2012 by the European Urogynaecology Association. She is also a college tutor in charge of trainees in obstetrics and gynaecology.
See more about Maria on Doctify and Linkedin.
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It’s crucial to understand both the clinical need and the needs of your customers for a device to succeed. Many companies may think they have a grasp on this, but true insight comes from collaboration real users. Documenting these needs and recognising potential risks is essential—after all, no customer means no device.
Additionally, remember that without the necessary regulatory approvals, your device won’t reach the market; therefore, consider the regulator as a key customer and involve them as a design input from the very beginning.