SMEDTEC OS is the regulatory operations command centre for medical device companies - a single, AI-searchable view of every product, every market, every registration, every claim, every piece of evidence, and every market-access status your organisation owns.

Most medtech regulatory teams cannot answer "where do we stand?" in under three days. SMEDTEC OS makes that answer available in one screen.

Built for two audiences: the growth-stage manufacturer scaling to multiple markets, and the regulatory consultancy managing multi-client portfolios. Both get a platform that is multi-market by default, audit-pack ready, and built for reusable evidence across every submission.

Regulatory frameworks covered: EU MDR · FDA 510(k) · UKCA · EUDAMED

Market access intelligence: NICE · CMS/Medicare · European HTA decisions, searchable by indication, device class, and reimbursement outcome. Because cleared isn't the same as covered.

Why SMEDTEC OS:

— 86% of medtech RA teams have no single source of truth (Veeva 2023)

— 77% report being under-resourced for their current workload (Celegence/RAPS 2024)

— Regulatory affairs outsourcing market: USD 6 billion in 2024, growing at 7.86% CAGR

SMEDTEC OS sits between the spreadsheet and the six-figure RIM platform, purpose-built for the teams the incumbents were not designed for.

Free trial available at os.smedtec.co.uk. No card required.

SMEDTEC OS

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SMEDTEC OS

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