Testimonials

It is my pleasure to provide a reference for Dr. Stephen Smith from Practical QA/RA. I worked with Stephen developing a novel robotic surgical system. Stephen brought a forensic knowledge to the area backed up by a sensible and pragmatic approach. His extensive knowledge allowed him to navigate a careful route through the process in sensible way as possible. His partner Dr Maria Vella brings a clinical maturity to the team. I cannot recommend Stephen and team more highly.

Dr. Mark Slack. Consultant Gynaecologist, Chief Medical Officer and Co-Founder, CMR Surgical Ltd.

https://cmrsurgical.com/management-team/mark-slack

Stephen Smith has something that a good QA RA expert needs - real world scar tissue. He’s seen the world of QARA when things are good and when things are tough. That is what you need as a company - experience. You also need experience in simple products - but more so in very complex and hard systems - such as surgical robots. This requires a high level view over the whole system, but more so the ability to get right down in the weeds of the sub systems - often very different systems - from software to disposables - to reusable - to semi reusable. And you also need to know how to navigate this across the global regulatory landscape and agencies. Stephen has demonstrated this time and time again. He has a final quality that any CEO, COO or CCO needs - pragmatism. You see there are clear rules for QARA but it is in the interpretation of those rules and the reading between the lines - in that grey area - where the skill of a good QARA professional comes in. Having worked closely with Stephen for years - I can attest that he knows how to navigate the grey areas and deliver pragmatic solutions that keep your company moving. Essential for start ups !!

Steve Bell - Medtech Expert