Regulatory operations,
built for precision
The regulatory operating system for medical device teams and the consultancies and authorised representatives that serve them. Manage products, submissions, and document control across every market, with AI-assisted intelligence and a full audit trail.
SOC 2 Infrastructure · UK & EU GDPR Compliant · EU MDR Workflow Ready · Immutable Audit Trail
Regulatory teams are running on spreadsheets, email, and hope.
Critical compliance data is scattered across tools that were never built for regulated industries. The risk compounds with every product.
No audit trail
Decisions and approvals live in email threads. When a notified body asks for evidence, reconstruction takes weeks.
Fragmented product data
Submission tracks, registrations, documents, and risk data sit in different tools with no cross-reference.
Manual everything
Regulatory timelines are tracked in shared spreadsheets. Deadlines slip. Overdue items get missed.
Everything your regulatory team needs, in one place
- MDR · FDA · ISO
Product & Submission Management
Define products, link classification codes, and manage submission dossiers across regulatory pathways, all from a single product record.
- 510(k) · PMA · CE · MHRA
Regulatory Tracks & Work Items
Break every submission into phased work items with status tracking, assignees, due dates, and dependency chains that mirror your real approval process.
- FDA · RWE · Audit-Ready
Real-World Evidence Documentation
For FDA 510(k), De Novo, and PMA submissions that rely on real-world data, capture the FDA December 2025 guidance metadata in one place: a structured source register with cover-letter fields, the Appendix A relevance & reliability checklist, and an append-only protocol version log. Documentation and traceability only; patient-level or clinical data is never stored or analysed.
- Technical Files · Submissions · Evidence
Regulatory Document Vault
A central, version-controlled store for the documents your regulatory team actually owns: technical files, submission packs, registration certificates, design evidence, and labelling. Role-based access, approval workflows, and immutable activity logging for every upload, review, and supersession. Complements your eQMS rather than replacing it.
- Multi-market
Country Registrations
Dedicated dashboards for MHRA, TGA, Health Canada, and EUDAMED. Track licence numbers, renewal dates, and holder details across every market your devices are sold in.
- PMS · SCA · Design Dossier · Audit
Lifecycle Management
Manage what happens after a product goes on sale: Post-Market Surveillance programmes with periodic reporting cycles, Significant Change Assessments per EU MDR Article 120 / FDA Letter-to-File, Design Dossier maintenance, and quality system Audit programmes (MDSAP, FDA inspections, notified body, ISO 13485). PMS programmes auto-spawn when a product enters 'selling'; track approvals automatically satisfy matching launch-readiness items.
- Consultancy · EU AR · UK RP · US Agent · TGA Sponsor
Rep Hub
Run consultancy and statutory representation from one workspace. Hold formal EU Authorised Representative, UK Responsible Person, US Agent or TGA Sponsor roles for your clients, each engagement tracked against its statute-cited obligations, jurisdiction identifiers (SRN, MHRA, FDA, ARTG) and renewal deadlines.
- Immutable · Audit Evidence
Audit Trail & Activity Log
Every action (document uploads, status changes, approvals, logins) is immutably logged with user, timestamp, and metadata. Tamper-evident audit evidence designed to support your validated compliance posture under EU MDR, ISO 13485, and equivalent frameworks.
See SMEDTEC OS in action
Platform uptime SLA
SOC 2 Type II
Client orgs per Rep Hub
Consultant or representative · unlimited on Scale
Regulatory frameworks supported
And growing
Regulator-specific dashboards
MHRA · TGA · Health Canada · EUDAMED
Simple, transparent pricing
Start with a free trial. Upgrade as your regulatory operations grow.
For small teams getting started with regulatory operations.
- 2 seats included (+£15/seat)
- Unlimited products
- Submission & track management
- Document vault (5 GB)
- Country registrations
- Full audit trail
- Email support
For growing teams managing multi-market submissions.
- 8 seats included (+£15/seat)
- Everything in Starter
- Document vault (25 GB)
- AI Intelligence (product chat, predicates)
- Password portals
- API integrations & Zapier
- Slack & Teams webhooks
- Priority support
For scaling organisations with large product portfolios.
- 25 seats included (+£10/seat)
- Everything in Growth
- Document vault (100 GB)
- Advanced reporting
- Dedicated onboarding
Enterprise
CustomFor organisations needing advanced compliance, SSO, and dedicated support.
- Everything in Scale
- Unlimited storage & seats
- SSO / SAML
- Custom integrations
- Dedicated account manager
- SLA guarantees
Ready to modernise your regulatory ops?
Join forward-thinking medical device teams building compliant products faster with SMEDTEC OS.
Frequently asked questions
What is SMEDTEC OS?
SMEDTEC OS is a regulatory operations platform for medical device teams. It brings your submissions, compliance tracking, technical documentation, and post-market activities into one secure workspace, so a small regulatory team can manage the full product lifecycle across multiple markets without stitching together spreadsheets and shared drives.
Who is SMEDTEC OS for?
It's built for medical device manufacturers (especially small and mid-size teams) as well as regulatory affairs and quality consultancies, and EU/UK authorised representatives who manage regulatory obligations on behalf of their clients.
Which regulatory frameworks and pathways does SMEDTEC OS support?
SMEDTEC OS is designed around EU MDR (CE marking), FDA pathways (510(k), De Novo, and PMA), and UKCA, with country registration tracking for markets such as the UK (MHRA), Australia (TGA), Canada (Health Canada), and EUDAMED. It aligns with ISO 13485, ISO 14971, and IEC 62304 ways of working.
Does SMEDTEC OS replace my eQMS?
No. It complements your eQMS rather than replacing it. SMEDTEC OS focuses on regulatory operations: managing submissions, maintaining the technical file, tracking registrations, and running post-market activities. It gives your regulatory team a purpose-built workspace alongside the quality system you already run.
How does SMEDTEC OS help with EU MDR compliance?
It helps you organise and evidence the work EU MDR requires: structuring technical documentation, tracking submission and renewal deadlines, managing post-market surveillance programmes, handling significant change assessments under Article 120, and keeping an immutable audit trail of every action. Compliance remains your responsibility. SMEDTEC OS makes the underlying work easier to manage and easier to demonstrate.
Can SMEDTEC OS help with FDA 510(k) submissions?
Yes. You can break each 510(k), De Novo, or PMA submission into phased work items with owners, due dates, and dependencies that mirror your real approval process. For submissions that rely on real-world evidence, it captures the FDA's real-world data guidance metadata: a structured source register and relevance/reliability checklist. It records documentation and traceability only; patient-level clinical data is never stored or analysed.
Is my data secure?
Security and data protection are core to the platform: role-based access control, approval workflows, and tamper-evident, immutable activity logging of every upload, review, and status change. See the Security page for details on our posture and data handling.
Can consultancies and authorised representatives use SMEDTEC OS?
Yes. The Rep Hub lets consultancies and statutory representatives run multiple client engagements from one workspace, holding formal EU Authorised Representative, UK Responsible Person, US Agent, or TGA Sponsor roles, each tracked against its statute-cited obligations, jurisdiction identifiers, and renewal deadlines.
SMEDTEC Intelligence
Free regulatory & market-access intelligence, in your inbox
What changed across EU MDR, FDA, and UKCA, with the data behind it. Plain English, no spam.