Contact us for pricing tailored to your organisation size, module requirements, and compliance scope.
Core QMS for small manufacturers getting started with CDSCO compliance
What's included
Full compliance suite for manufacturers targeting ISO 13485 certification or FDA/EU export
What's included
All modules for enterprise manufacturers exporting to US and EU regulated markets
What's included
No setup fees • Contact info@mdcyclonova.com for pricing
| Feature | Starter | Essential | Full Platform |
|---|---|---|---|
| Core QMS | |||
| Core QMS Modules | ✓ | ✓ | ✓ |
| CRM & Enquiries | ✓ | ✓ | ✓ |
| Document Control & DCOs | ✓ | ✓ | ✓ |
| Teams Management | ✓ | ✓ | ✓ |
| E-Signatures (21 CFR Part 11) | ✓ | ✓ | ✓ |
| Audit Trail (WORM — immutable) | ✓ | ✓ | ✓ |
| Compliance Modules | |||
| DHF Management | — | ✓ | ✓ |
| CAPA & NCR | — | ✓ | ✓ |
| Risk Management (ISO 14971) | — | ✓ | ✓ |
| Audit Management | — | ✓ | ✓ |
| Supplier Management | — | ✓ | ✓ |
| Training Records | — | ✓ | ✓ |
| QMS Tracker Dashboard | — | ✓ | ✓ |
| Operations & Enterprise | |||
| Shipments & Travellers | — | — | ✓ |
| Projects Module | — | — | ✓ |
| Inventory Management | — | — | ✓ |
| Purchase Orders | — | — | ✓ |
| Invoice Management | — | — | ✓ |
| Project Management & Budget Tracking | — | — | In Dev |
| Multi-site Support | — | — | ✓ |
| FDA / EU MDR Export Pack | — | — | ✓ |
| Platform & Support | |||
| AWS S3 WORM Storage (ap-south-1) | ✓ | ✓ | ✓ |
| Cognito MFA Authentication | ✓ | ✓ | ✓ |
| Multi-tenant Architecture | ✓ | ✓ | ✓ |
| AI Assistant | Add-on | Add-on | Add-on |
| Users | Up to 10 | Up to 25 | 50–100 |
| Priority Support | — | ✓ | ✓ |
| Dedicated CSM Onboarding | — | — | ✓ |
| Custom Integrations | — | — | ✓ |
For enterprise deployments, multi-site configurations, on-premises hosting, or custom compliance integrations — contact us for a tailored proposal. We respond within one business day.
Contact Enterprise Team → info@mdcyclonova.comContact info@mdcyclonova.com to book a demo or request pricing. We'll set up your organisation and walk you through the platform — no commitment required to explore.
Pricing is based on the modules you need, the number of users in your organisation, and your compliance requirements (CDSCO only, full ISO 13485, or FDA/EU MDR export pack). Contact us and we'll send a clear, line-item proposal within one business day.
All data for Indian customers is stored on AWS Mumbai (ap-south-1). Your compliance records, audit trails, and documents never leave Indian soil — meeting regional data residency requirements. Storage uses S3 Object Lock WORM with KMS encryption at rest.
Yes. MDCN Studio supports bulk import of existing SOPs (PDF or ZIP batches), supplier records (CSV), and employee/training data. Our onboarding guide walks your QA Manager through the full import process. For complex migrations, the Full Platform includes a dedicated Customer Success Manager.
MDCN Studio covers CDSCO MDR 2017 (Schedule 5 — all 12 clauses), ISO 13485:2016 (Sections 4–8 — 28 clauses), FDA 21 CFR Part 11 (all 17 applicable sections), and EU MDR 2017/745 (Annex IX — 11/12 requirements). See the full compliance matrix for clause-by-clause detail.
Monthly and annual agreements are available. Annual plans typically include priority support and a better rate. There is no long-term lock-in — contact info@mdcyclonova.com to discuss options.
All plans include email support and access to the knowledge base. Starter: 48hr response. Essential: 24hr response. Full Platform: 4hr response (business hours IST) with a dedicated Customer Success Manager and monthly strategy call.
Yes. User seat adjustments are handled by our team. Contact info@mdcyclonova.com to add users or upgrade your tier as your organisation grows.