Medical Device · IVD · Cosmetics · Compliance Technology

Regulatory work,
scoped up front

Classification assessments, regulatory position notes, technical documentation builds and QMS programmes, delivered as scoped projects with the boundary agreed in writing before we start. For medical device, IVD and cosmetics teams who would rather know what they are buying.

See the project packages →Book a scoping call
Building the operating system for modern compliance, where human expertise meets intelligent technology.
SMEDTEC · Mission
10+
Years in MedTech RA
EU·UK·US·AUS·CAN·ROW
Global Reach
New · 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, for a fixed fee and with no scoping call.

Check your product's status →£249 + VAT
  • Status for Great Britain and the EU, with the reasoning
  • Each of your claims marked fine, at risk or crossing the line
  • The route to market and the obligations that follow
  • Reviewed and released by a qualified consultant
What We Do

Defined projects.
Intelligent platforms.

Most work starts as a scoped project with a fixed fee and a written boundary. From there we can stay embedded, put you on the platform, or build the system you own. Devices, IVDs and cosmetics, including borderline products.

01
Regulatory Projects

Defined pieces of work with a fixed scope and a fixed fee: classification and pathway assessments, regulatory position notes, technical documentation builds, QMS planning and build. You know the scope, the exclusions and what you receive before the work starts.

02
Embedded RA/QA

Fractional regulatory and quality leadership for teams that need expertise on tap rather than a single deliverable. Strategy through post-market surveillance across medical devices, IVDs and cosmetics, including borderline products, plus UK Responsible Person appointment where you need it.

03
SMEDTEC OS

Our AI-powered regulatory operations platform, giving regulatory teams the tools to work smarter, move faster, and stay audit-ready at every stage. It is also the system we run your project on.

04
Compliance Studio

Bespoke compliance tools built on your own infrastructure, with your own IP: custom AI integrations, compliance operations and supply-chain optimisation. Where SMEDTEC OS is our platform, Compliance Studio is yours, engineered around you.

See the project packages →All services →
Our Technology Arm

Meet SMEDTEC OS

Born from years of regulatory practice, SMEDTEC OS is our standalone SaaS platform for medical device regulatory teams. Manage submissions, registrations, document control, and compliance workflows in one auditable, AI-enhanced platform.

Visit SMEDTEC OS →
End-to-end submission pipeline management
EU MDR, IVDR & FDA 21 CFR Part 11 ready
Document control with full audit trail
Global registration tracking
Built for lean MedTech regulatory teams
Entering SMEDTEC OS
Regulatory Operations Platform

Regulatory operations,
built for precision

The end-to-end regulatory operating system for medical device teams. Manage products, submissions, registrations, and document control in one auditable platform.

→Submission pipeline
→Registration tracking
→Document control
→Command centre
→Automated alerts
→AI gap analysis
SMEDTEC OS dashboard
Bespoke Compliance Engineering

Meet Compliance Studio

Some teams want a platform; others want compliance engineered into their own systems. Compliance Studio builds bespoke tools, AI integrations and operational workflows on your infrastructure: your IP, your stack, our regulatory and engineering expertise.

Explore Compliance Studio →
Custom AI integrations for compliance workflows
Compliance operations tooling on your own stack
Supply-chain and quality data optimisation
You own the IP and the infrastructure
Built to slot into your existing systems
Credentials

Led by founder Sherif Elkhadem, RAC (Devices) certified, with over a decade of experience in the medical device and biopharmaceutical industries. About SMEDTEC

RAPS RAC Devices: Regulatory Affairs CertificationRAC (Devices) certified
Verify on bcert.meBIVDA MemberMember of BIVDA
Get Started

Ready to scope the first project?

Tell us the question. A short scoping call gives you the package, the boundary and the fee before you commit to anything.

Book a scoping callSee the packages