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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To see if our service is right for you or for some free guidance please complete the form
Contact Us
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
Fractional Quality Assurance and Regulatory resource
In massage therapy, I use a variety of techniques to suit your individual needs.
Remediation or Audit Preparation work
Physiotherapy is a dynamic and pro-active approach to your physical rehabilitation.
Quality, Regulatory and Clinical Consulting
As an experienced chiropractor, I’ll help you cope with daily aches and pains.
Country Representation and Sponsorship
Physical therapy can help ease the discomforts associated with pregnancy.
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.
Our Experts
Dr. Stephen Smith
QA/RA Expert, Co-Founder
stephen@practicalqara.com
Dr. Maria Vella
Clinical Adviser, Co-Founder
maria@practicalqara.com
