Regulatory consultancy, with a written boundary
Regulatory work,
scoped up front.
Classification assessments, regulatory position notes, technical documentation builds and QMS programmes. Scoped projects, with the boundary agreed in writing before we start.
Classification assessments, regulatory position notes, technical documentation builds and QMS programmes. Know the scope, exclusions and deliverables before we start.
View project packages
Fractional regulatory and quality leadership, from strategy through post-market surveillance. Including UK Responsible Person appointment where you need it.
Explore embedded support
Our regulatory operations platform. Submissions, registrations, document control and compliance workflows in one auditable workspace. It is also the system we run your project on.
Explore SMEDTEC OSBespoke compliance tools, AI integrations and operational workflows, built on your own infrastructure. Your IP, your stack, engineered around you.
Meet Compliance Studio
10+ yearsin MedTech regulatory affairs
RAC (Devices)Certified regulatory expertise
EU, UK, US & beyondAUS, CAN and rest of world
Defined projects.
Intelligent platforms.
A clear boundary, before we start.
For medical device, IVD and cosmetics teams who would rather know what they are buying. Start with a fixed-fee project. Stay embedded, use the platform, or build the system you own.
Product Status Check
Cosmetic, medical device,
or somewhere in between?
Answer a short questionnaire about your product and get a written opinion on its regulatory status. Fixed fee. No scoping call.
£249+ VAT · fixed fee
Check your product’s statusWhat your written opinion covers
Your product’s regulatory status
A written opinion for Great Britain and the EU, with the reasoning behind it.
A review of your product claims
Each claim marked fine, at risk or crossing the line.
The route and obligations that follow
Reviewed and released by a qualified consultant.
For devices, IVDs, cosmetics and borderline products.
Our technology arm
Expertise that comes
with a better way to work.
Born from regulatory practice. Built to manage submissions, registrations, document control and compliance workflows in one auditable platform.
Meet SMEDTEC OSOur platform
SMEDTEC OS
Your regulatory operations, together. The platform we use to run your project is available to your team too.
Explore the platformYour infrastructure
Compliance Studio
Custom AI integrations, compliance operations and supply-chain tools. Built on your stack, with your own IP.
Meet Compliance StudioThe people behind the work
Regulatory judgement.
Human accountability.
Led by Sherif Elkhadem, RAC (Devices) certified, with over a decade of experience in the medical device and biopharmaceutical industries.
About SMEDTECReady to scope
the first project?
A scoping call gives you the package, the boundary and the fee.