MDCycloNova exists to solve one problem: medical device manufacturers deserve a QMS that speaks their regulatory language — not a repurposed global tool with a price tag they can't afford.
India has over 10,000 licensed medical device manufacturers. More than 90% manage their Quality Management System in Excel spreadsheets, paper binders, and email chains. When CDSCO inspectors arrive — or when an ISO 13485 certification audit begins — those systems fall apart.
Global QMS software exists — but it is priced for US and European companies, has no CDSCO localisation, and takes 6–12 months to implement. That is not a solution for a mid-size manufacturer with a QA team of five people.
We built MDCN Studio to close that gap. A cloud-native QMS purpose-built for CDSCO MDR 2017, with ISO 13485, FDA 21 CFR Part 11, and EU MDR built in from day one. Implementation in 14 days, not months. Data stored in your region. Pricing designed to fit your market.
CDSCO MDR 2017, ISO 13485, FDA 21 CFR Part 11, and EU MDR are built into every feature — not bolted on. Whichever regulation you face, MDCN Studio speaks it natively.
Every module was designed with a specific CDSCO or ISO 13485 clause in mind. Compliance is built in — it is not a feature layer on top of a generic SaaS platform.
Manufacturers cannot afford 6-month implementations. We target 14 days from sign-up to a functioning, audit-ready QMS with real data in it.
Our ideal customer is a QA Manager at a 100-person device manufacturer. Every UX decision is optimised for that person — not an IT administrator or a US compliance officer.
MDCycloNova was built by two founders with hands-on experience in medical device compliance, regulated SaaS architecture, and AWS cloud infrastructure.
Founder · Product & Engineering Lead
12+ years of experience in the software industry. Deep expertise in regulated SaaS, cloud infrastructure, and enterprise software — applied to every architectural decision in MDCN Studio.
Founder · Domain & Regulatory Lead
Medical device regulatory affairs, CDSCO submission experience, ISO 13485 audit preparation, and manufacturer network. The compliance domain expertise behind every feature decision.
Advisory network includes CDSCO-registered quality consultants and ISO 13485 lead auditors. Every product decision is validated against real compliance manager workflows.
MDCN Studio is not a prototype or an MVP. 22 modules are live on AWS with production-grade infrastructure, with Project Management & Budget Tracking in active development designed for SOC 2 readiness and ISO 27001 alignment from day one.
Auto-scaling container hosting for NestJS API and Next.js frontend. Managed TLS. No cluster management overhead.
Managed PostgreSQL with automated backups and Multi-AZ failover readiness. All tenant data in ap-south-1.
Immutable record storage satisfying FDA 21 CFR Part 11 §11.10(e). Documents cannot be modified or deleted after approval.
Managed identity provider with mandatory MFA. Satisfies 21 CFR Part 11 §11.200 electronic signature identity requirements.
Customer-managed encryption keys for database and S3. Required for ISO 27001 and SOC 2 readiness.
Indian customers are hosted on AWS Mumbai (ap-south-1) for data residency. International customers are hosted in their nearest AWS region — US, EU, or Asia-Pacific — for performance and local compliance.
For demos, pricing, compliance questions, or partnership inquiries — we respond within one business day.
Whether you're scoping a demo, requesting pricing, asking a compliance question, or exploring whether MDCN Studio fits your operations — drop us a line and we'll get back to you fast.
Business hours: 9am–6pm IST, Monday–Friday.
For urgent production issues, include [URGENT] in your subject line.
Compliance Questions?
For questions like "how does MDCN Studio satisfy CDSCO Clause X?" — email admin@mdcyclonova.com directly.