Your Expert Partner in Medical Device Quality Assurance and Regulatory Affairs

At Practical QA/RA, we provide flexible, experienced, and pragmatic Quality Assurance (QA) and Regulatory Affairs (RA) support for medical devices and IVD's

Why Choose Practical QA/RA?

✓ Extensive Experience in the Real World

With over 25 years in the MedTech industry and more than 25 years of clinical experience, we've seen it all — the good, the bad, and the avoidable. From helping devices succeed to spotting what leads to failure, our insight goes far beyond theory.


✓ Focused, Flexible, and Fast

We’re not just consultants — we’re problem-solvers. Whether you need a compliant Quality Management System, Fractional QA or RA support, help with submissions, support preparing for an audit, or clinical advice using a qualified medical consultant we provide bespoke, effective guidance tailored to your product and pathway.


✓ Collaborative, Not Generic

We work closely with your team, combining our technical expertise with your product knowledge to build practical, workable solutions — not off-the-shelf templates.


✓ Global and Agile Support

Based near Cambridge UK we also have bases in Scotland, EU and New Zealand. We can provide on-site and remote support across the UK and internationally and can be available at short notice.

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Our Services

We are dedicated to providing practical QA/RA Solutions to medical device designers and manufacturers. See more about us and the services we offer

Our Services

Ready to Move Forward?

If you need Fractional resource, preparing for an audit, launching a product, or strengthening your QMS, we're here to help. We offer a free initial consultation to help assess your needs and determine whether our services are the right fit.

 

Let’s make your device safe, effective, and compliant — the practical way.

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Our Experts

Dr. Stephen Smith

QA/RA Expert, Co-Founder

stephen@practicalqara.com

Dr. Maria Vella

Clinical Adviser, Co-Founder

maria@practicalqara.com

Need to Speak to an Expert?

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