For manufacturers
Working with a SMEDTEC OS firm.
If your representative or consultancy runs on SMEDTEC OS, keep your regulatory record in a workspace of your own: one product record for pathways, registrations and post-market. Let the firm in one product at a time, read-only, only when you approve. Or have the firm run a workspace for you.
Or start your own workspace on a free trialFree 14-day trial · Auditable from day one
Enterprise-sized obligations, a three-person team, and a shared spreadsheet.
Small regulatory teams carry the same duties as large ones across every market they sell in. The tooling was never built for that.
Registrations live in spreadsheets
Licence numbers, renewal dates and holder details for each market sit in a sheet nobody owns. A missed renewal is a market you can no longer sell in.
Post-market creeps up on you
Surveillance reports, significant-change assessments and audit programmes start late because nothing tells you they are due.
Audits mean an evidence hunt
When a notified body or the FDA asks for the decision trail, it gets reconstructed from email threads over days.
Every submission is a fresh plan
510(k), CE and UKCA work is planned from scratch each time, with no dependencies, no shared owner list and no record of what changed.
What your own workspace gives you
- Connected · Managed
Two ways to work with your firm
Run your own workspace and approve your firm's request to connect: you choose the products it sees, read-only, and can end access at any time. Or let the firm manage a workspace for you, with read-only access for your team to its own products, documents and status.
- EU MDR · 510(k) · UKCA · TGA · Health Canada
Product record and regulatory pathways
Define each device once with its classifications, SKUs and target markets. Break every submission — EU MDR, 510(k), De Novo, PMA, UKCA, MHRA, TGA, Health Canada — into phased work items with owners, due dates and dependencies that mirror your real approval process.
- MHRA · TGA · Health Canada · EUDAMED
Country registrations
Registrations are tracked per product and market, with licence numbers, renewal dates and holder details for MHRA, TGA, Health Canada, EUDAMED and more. Launch-readiness checks gate the move from launching to selling.
- PMS · SCA · Design dossier · Audit
Post-market lifecycle
Post-market surveillance programmes start their reporting cycles automatically when a product goes on sale. Significant-change assessments (EU MDR Article 120, FDA Letter-to-File), design dossier maintenance and audit programmes are tracked with the same discipline.
- Vault · Audit pack · SHA-256 manifest
Document vault and audit packs
Technical files, submission packs, certificates and labelling with supersession tracking, role-based access and approval workflows. Bundle any scope into an audit pack with a SHA-256 manifest so an auditor can verify exactly what they were given. Complements your eQMS rather than replacing it.
- Requests · Triage · Convert
Intake portal
Give sales, engineering and marketing a structured way to raise regulatory requests. Triage with AI assistance and convert an accepted request into tracked work in one step, so the paper trail starts at the question.
- Regulatory updates · Competitors · HTA
Intelligence and market access
A daily feed of regulatory developments, competitor clearances, recognised standards and HTA decisions, routed against your markets and device classes — the commercial signal most compliance tools leave out.
- Grounded · Cited · Abstains
Datum assistant
Ask questions of your own vault, products and registrations. Datum retrieves before it answers, cites what it used, and abstains when it has no evidence.
- Immutable · Evidence
Immutable audit trail
Every upload, status change, approval and login is logged with user, timestamp and metadata. Tamper-evident audit evidence aligned to EU MDR and ISO 13485 ways of working.
- Consent · Per product · Revocable
Connected firms
Your representative or consultancy asks to connect; you approve, switch on the products they may see, and can end access at any time. Their view is read-only, and every change is recorded in your activity log.
EU MDR · FDA · UKCA · TGA · Health CanadaImmutable audit trailBuilt on SOC 2 compliant infrastructureUK & EU GDPR
Pathway types
US · EU · UK · Canada · Australia and more
Regulator dashboards
MHRA · TGA · Health Canada · EUDAMED
Regulatory frameworks
And growing
Platform uptime SLA
Published commitment
Questions from teams like yours
Our firm uses SMEDTEC OS. Do we need a workspace of our own?
No. Your firm can hold you as a client in its own workspace, or run a workspace on your behalf with read-only access for your team. A workspace of your own is for when you want your regulatory record held by you, so it stays where it is if you change firm.
How does SMEDTEC OS work alongside our eQMS?
It complements it. CAPA, complaints handling and training records stay in your quality system. SMEDTEC OS runs the regulatory work — submissions, registrations, post-market cycles and the evidence behind them — and keeps the audit trail for it.
What happens when a product goes on sale?
Launch-readiness checks confirm the registrations and approvals are in place, and the product's post-market surveillance programme starts its reporting cycles automatically. Significant-change assessments and audit programmes are then tracked against that product for as long as it is on the market.
Can people outside the regulatory team raise requests?
Yes. The intake portal gives colleagues a low-trust requester role: they submit through forms your team designs, your team triages, and an accepted request becomes tracked regulatory work with the original question preserved.
Do you store patient-level or clinical data?
No. The real-world evidence features record documentation and traceability only — a source register, the relevance and reliability checklist and a protocol version log. Patient-level or clinical data is never stored or analysed.
Do we have to give our consultancy access to everything?
No. A firm sees none of your product records until you approve its request and switch products on, one at a time, read-only. Access is managed from Settings, under Team, and you can narrow or end it whenever you like.
See what your own workspace looks like.
Take the four-minute interactive demo on fictional data. When you're ready, start your own workspace on a free 14-day trial: your firm requests the connection, and you approve it.
Explore the interactive demo