Regulatory Intelligence Platform

Your path to market,
without the chaos.

ComplyOS maps your device to the right regulatory pathway, builds your compliance checklist, and connects you to expert support — in minutes, not months.

Start now See how it works
Aligned with global regulatory frameworks
HSA Singapore
FDA United States
IMDRF
IEC 60601
ISO 13485
How it works

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.

🇸🇬
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 / C SaMD GL-07 Abridged Route IMDA Approval
🇺🇸
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 Novo PCCP AI/ML Guidance
🇪🇺
European Union — MDR
Full EU MDR 2017/745 support. CE marking, Notified Body routes, IVDR coverage, and SaMD classification under MDCG guidance.
CE Marking EU MDR IVDR MDCG
🇦🇺
Australia — TGA
Full TGA ARTG registration support. Covers Class I through III devices, AUMDRS harmonisation pathways, and mutual recognition with IMDRF member countries.
ARTG Class I–III AUMDRS IMDRF
🇯🇵
Japan — PMDA Coming soon
PMDA regulatory support in development. Covers Class II/III Shonin approval, Class I Todokede notification, and SaMD classification under MHLW guidelines.
Shonin Todokede PMDA SaMD
🇬🇧
United Kingdom — MHRA Coming soon
UK MHRA registration support in planning. Covers UKCA marking, Class I–III devices, and Software as a Medical Device guidance post-Brexit.
UKCA UK MDR MHRA SaMD
● 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.

Start with ComplyOS Learn about SETSCO

Your device deserves a
clear path forward.

No regulatory consultant on retainer. No months of confusion. Just a clear plan, from intake to submission.

Open ComplyOS dashboard