Stephen Smith

QA/RA Manager

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Stephen joined Medovate in September 2020 and has over 20 years’ experience in quality and regulatory.

At Medovate he is responsible for managing the quality management system and regulatory strategies by ensuring they comply and the products meet clinical needs.


He talks us through his busy role as a QA/RA Manager at Medovate.

What does a 'typical' day involve for you?

Not sure if there is any such thing as a typical day. The pace of regulatory change makes compliance a complex environment, and there is always material to write or review, a plethora of regulations to meet and systems to improve. As the company is dynamic the quality system needs to continually evolve to make it fit for purpose, so it is a bit like painting the Forth Bridge in that respect. Overall, the goal is ensuring that as a manufacturer we make high quality products that make a difference to real people.

What attracted you to apply for your role and work at Medovate?

I have first-hand experience of the huge knowledge base within the NHS and believe that the best inventions or ideas come from those who stand to use them – in our case clinicians. Medovate appeared different in that they worked directly with those on the front line through the development process, hence maximising the value of clinical involvement throughout the device lifecycle. This is in contrast to many companies who develop products that seem like a good idea but are often developed solely by engineers with little clinical input until it is too late.

What are the main challenges in your role (and how do you manage them?)
The biggest challenge is implementing systems that are not only compliant but also work effectively and commensurate the business model. Pragmatism and usability in internal systems are just as important as those in the device. I tend to manage them by taking a risk-based approach, by looking at what we want systems and devices to do, what may cause them to fail and finding ways of preventing failure. It is much harder in the short term but builds good foundations in the long run.

What is the best thing about working at Medovate?

Simple, the culture and an experienced team. Everyone is treated as equals. We all bring something different to the table while complementing each other’s skills and talents.

Describe the Medovate culture in 3 words

Down to earth.


And finally, a bit about yourself:

Favourite food – Lasagne
Favourite TV program
– Have I got News for You
What do you do to relax/hobbies?
– Work on my classic car – a Triumph TR6, or DIY.
Something your colleagues don't know about you
– Before getting into the exciting world of QA/RA I used to be a coach driver for 18-35 holidays and have a licence to drive pretty much anything you see on the road. I’m also going for my private pilots licence.

More about Stephen's experience:

Having worked with a wide range of companies such as Bayer Diagnostics, Sphere Medical, TwistDx and more recently CMR Surgical, he has gained experience in a wide range of devices from blood gas analysers and molecular diagnostics to surgical robotics.

Working with both start-up companies as well as multinationals, Stephen has had a broad exposure to various quality and regulatory approaches and has had to adapt to changes in requirements over time by finding solutions that are not only compliant but are also pragmatic and work for the business.

Stephen holds a Bachelors and Masters degree in Geography from the University of Canterbury in New Zealand, a Masters in Medical Diagnostics and a PhD in Quality Management from Cranfield University. He is also a fellow of the Chartered Quality Institute (CQI) and a member of the CQI’s content advisory panel.