Replace scattered Word templates with structured frameworks + AI auto-fill — from COA/IFU/SDS to regulator-ready PDFs across 35+ markets.
35+
Countries
46
Frameworks
2400+
Regulatory Fields
100%
Compliance Coverage
Now viewing
Document
Device Master File (IVD)
CDSCO-aligned sections with AI-assisted drafting.
Completion
62%
Versioned
Try it
“Show pending fields and auto-fill from uploaded COA.”
Trusted by teams who ship submissions
How it works
No consultants. No Word templates. No duplicated effort.
Enter your device details once — name, manufacturer, class, intended use.
Choose from 35+ countries. Each market shows available submission types.
One click creates the full regulatory document with all required sections.
Upload source documents or type answers. AI helps fill fields accurately.
Review, version, and export compliant PDFs ready for submission.
Platform
Every feature designed to eliminate the pain of medical device documentation.
Every field in every framework is mapped to real regulatory requirements — CDSCO DMF, FDA 510(k), EU MDR, NMPA, PMDA, and 40+ more. No generic templates.
Upload COAs, clinical reports, IFUs, or safety data sheets. Our AI extracts relevant data and maps it to the correct regulatory fields automatically.
Register one product, select target markets. SwayamSutra generates country-specific regulatory documents with the correct structure, fields, and language requirements.
Every change is tracked. Create versioned snapshots, compare revisions, and maintain the complete audit trail regulators require.
Enterprise-grade encrypted storage for all regulatory documents. Role-based access, download controls, and complete traceability.
Generate print-ready PDFs in the exact format each authority requires. A4, Letter, structured annexes — all handled automatically.
Global coverage
The most comprehensive medical device regulatory platform in the world.
Asia
5 countriesAmericas
7 countriesEurope
5 countriesOceania
2 countriesSoutheast Asia
7 countriesMiddle East
4 countriesAfrica
3 countriesSouth Asia
2 countriesWithout SwayamSutra
With SwayamSutra
Pricing
Start free. Scale as your regulatory portfolio grows.
For small manufacturers entering 1-2 markets
For growing companies with multi-market ambitions
For organizations managing global portfolios
Proof
Built to reduce submission time, risk, and stakeholder friction.
“We turned a multi-country submission plan into a structured, trackable workflow. The biggest win: one source of truth across teams and markets.”
Head of Regulatory Affairs
IVD Manufacturer
“The framework structure is the difference. It’s not a template library — it’s a compliance system that mirrors how regulators actually evaluate dossiers.”
Regulatory Consultant
Global Consultancy
“Versioning + document vault removed the chaos. Audits went from stressful to routine because the trail is already there.”
Operations Lead
Medical Device Company
FAQ
Everything you need to evaluate the platform.
No. Each country framework is built as structured sections + fields aligned to the authority’s expectations (e.g., CDSCO, FDA, EU MDR/IVDR, NMPA, PMDA).
Team
Combined 55+ years of regulatory, AI, and operations expertise.
15+ years founding India's leading CDSCO consulting organization. Deep expertise in import licensing, IVD distribution, and multi-country submissions.
Built multiple AI products serving Indian enterprises. Expertise in NLP, document understanding, and building products that scale to millions of users.
25+ years in the IVD industry. Expertise in operations, supply chain, IT infrastructure, regulatory compliance, and cybersecurity.
Start shipping submissions
Consolidate frameworks, documents, and collaboration into one submission workspace — built for global scale.