ComplyOS maps your device to the right regulatory pathway, builds your compliance checklist, and connects you to expert support — in minutes, not months.
From device idea to submission-ready in one platform.
01
Tell us about your device
Six targeted questions — device type, function, components, target markets. No regulatory knowledge required. Takes under 5 minutes.
Intake
02
We determine your pathway
ComplyOS classifies your device, maps the exact regulatory pathway for each market, and generates your sequencing strategy automatically.
Classification & Roadmap
03
Build your compliance file
A personalised checklist of every required document, test, and certificate. Upload what you have — AI evaluates each item and flags gaps instantly.
Checklist & Gap Analysis
Platform features
Everything your team needs to move faster.
Built for medical device companies and R&D teams navigating HSA, FDA, and beyond. No compliance background required — ComplyOS translates regulatory complexity into a clear, actionable plan.
Instant device classification
Answers six questions and returns your regulatory class, applicable pathway, and risk level for every target market.
Market sequencing strategy
AI determines the optimal order to file across markets — and explains exactly why, with timeline and cost implications.
Per-item document upload
Upload evidence against each checklist item individually. AI evaluates existence, scope match, and completeness — not just filename.
Gap analysis with actions
Every failed document gets a specific finding: what's wrong, which standard it violates, and exactly what to fix before resubmitting.
Submission readiness score
Live progress bar across all 28+ required items. Filter by market, priority, or SETSCO-executable items at any time.
One-click SETSCO handoff
Connect to a SETSCO specialist with a single click. They receive your full profile, roadmap, and gap status before the first conversation.
Supported markets
Built in Singapore. Designed for the world.
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Singapore — HSA
Full support for HSA Health Products Act registration. ComplyOS covers Class A through C devices, SaMD classification under GL-07, and CSDT dossier requirements.
Class A / B / CSaMD GL-07Abridged RouteIMDA Approval
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United States — FDA
510(k), De Novo, and PMA pathway support. Covers PCCP requirements for AI/ML-enabled devices, SBOM, FDA 2023 cybersecurity guidance, and SaMD AI/ML framework.
510(k)De NovoPCCPAI/ML Guidance
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European Union — MDR Coming soon
EU MDR 2017/745 support in development. CE marking, Notified Body routes, and IVDR coverage planned for Q3 2026.
CE MarkingEU MDRIVDR
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Australia — TGA Coming soon
TGA ARTG registration support in planning. Includes AUMDRS harmonisation pathways and mutual recognition with other IMDRF members.
ARTGAUMDRSIMDRF
● Expert human support
When you're ready, SETSCO steps in.
Asia's leading testing, inspection and certification partner. One click connects you to a specialist who already knows your device, your gaps, and your timeline — no briefing required.