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

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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 

www.howtostartupinmedtech.com

 

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During the phases of medical device development, you need someone who has the appropriate breadth of knowledge and is capable of the necessary regulatory rigour. Stephen has proven to me on numerous occasions that he is more than capable of meeting the required high standards.  

He is someone you can trust to do a thorough job, particularly when implementing ISO13485.  He's a very approachable and practical person too, who can appreciate some of the tough challenges that device development can throw up.  I wouldn't hesitate in recommending Stephen again when my clients need his specialist skills.

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Martin Richardson, Technical Director,

Micro Engineering Consulting Ltd.

https://www.meconservices.co.uk

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