The only QMS that speaks CDSCO MDR 2017, ISO 13485, and 21 CFR Part 11 natively — with AI built in. 23 modules. Multi-region cloud hosting.
90%+ of medical device manufacturers still manage QMS documentation in Excel, paper binders, and email chains — and it shows during CDSCO audits.
CDSCO inspectors require traceable document version histories, e-signatures, and CAPA closure evidence. Manual systems cannot produce them reliably.
Incomplete Design History Files are the #1 reason CDSCO rejects device registration applications, delaying market entry by months.
Without version control and e-signatures, teams unknowingly operate on outdated SOPs — creating non-conformances that cost weeks to resolve.
ISO 13485 certification and FDA 21 CFR Part 11 compliance are prerequisites for US and EU exports — but manual QMS cannot generate the required audit evidence.
23 integrated modules built around the regulations you need to comply with — CDSCO first, then ISO, FDA, and EU MDR. Now including Inventory Management, Purchase Orders, and Invoice Management for end-to-end operational control.
Complete device lifecycle documentation with e-signatures. Every design input, output, verification, and validation — traceable and audit-ready from day one.
Version-controlled SOPs, DCOs, and quality documents with multi-level approval workflows and 21 CFR Part 11 compliant e-signatures.
Corrective and preventive actions tracked from detection to verified closure. Non-conformances identified, investigated, and resolved with a full audit trail.
ISO 14971-aligned risk register with severity/probability matrix and mitigation tracking. Linked to your DHF and post-market surveillance data.
Plan internal audits, host CDSCO and notified body inspections, and close out findings with full evidence capture in a single workspace.
Generate SOPs, run compliance gap analyses, and get regulatory guidance instantly. AI that actually understands CDSCO and ISO 13485.
The only India-priced platform that covers CDSCO, ISO 13485, FDA 21 CFR Part 11, and EU MDR simultaneously — with every feature mapped to a specific clause.
Central Drugs Standard Control Organisation
Quality Management System
Electronic Records & Signatures
European Union MDR
Most QMS implementations take 6–12 months. MDCN Studio targets a fully onboarded organisation in 30 days — with pre-loaded templates for CDSCO and ISO 13485.
Set up your org profile, CDSCO licence number, regulatory scope, and branding. No IT team required — your QA Manager can do it alone.
Upload your existing SOPs as PDF or ZIP batches. MDCN Studio becomes the version-controlled repository from day one.
Select CDSCO, ISO 13485, FDA, or EU MDR. The platform activates the relevant clause sets, approval workflows, and e-signature rules automatically.
Role-based invitations, mandatory MFA, and an onboarding checklist that walks every team member through their first QMS actions.
Contact us for pricing tailored to your organisation size, module needs, and compliance requirements.
Core QMS for small manufacturers getting started with CDSCO compliance
Included
Full compliance suite for growing teams targeting ISO 13485 certification
Included
All modules for enterprise manufacturers exporting to US & EU markets
Included
No setup fees • Contact us for pricing
Not a generic chatbot. An AI trained on CDSCO, ISO 13485, 21 CFR Part 11, and EU MDR — that generates real compliance content and checks your gaps.
Describe the process, get a complete CDSCO or ISO 13485 aligned SOP draft. QA Manager reviews and approves via the Document Control workflow.
Run a clause-by-clause gap analysis against CDSCO Schedule 5, ISO 13485 Sections 4–8, or 21 CFR Part 11. Get a prioritised remediation list.
Ask any CDSCO, ISO 13485, or FDA question and get a sourced, accurate answer. No more searching through PDF regulations.
Generate CDSCO Form 34B inspection checklists or ISO 13485 internal audit checklists tailored to your device class and process areas.
Every feature was designed with a CDSCO or ISO 13485 clause in mind — not adapted from a generic global template.
Years of Healthcare IT expertise behind every QMS workflow — built by operators who have lived the compliance problem.
Integrated modules covering the full QMS lifecycle — Documents, DHF, CAPA, Audits, Risk, Suppliers, Inventory, Purchase Orders, Invoices, and more.
Regulatory frameworks covered simultaneously: CDSCO MDR 2017, ISO 13485:2016, FDA 21 CFR Part 11, EU MDR 2017/745.
Day onboarding target. Not 6–12 months like global tools. Up and running with your first compliance workflows in two weeks.
Indian customers: AWS Mumbai (ap-south-1). International customers: hosted in their nearest AWS region — US, EU, or Asia-Pacific. Full data residency, always.
S3 Object Lock WORM, KMS encryption at rest, Cognito MFA, and immutable audit trails built into every module.
Every module maps to a specific CDSCO, ISO 13485, or FDA clause — validated with CDSCO-registered QA managers.