One workspace for ISO 13485, EU MDR/IVDR, FDA QMSR, MDSAP, IEC 62304, ISO 14971, ISO 14155, the EU AI Act — and every clinical trial, PMCF, patient-advisory and design-control record they touch. Built for SaMD, AI-enabled and traditional devices, from first idea to post-market.
VitaQMS is a software tool that assists with templates, workflows and evidence traceability. The customer is solely responsible for the validation, customization, implementation and effectiveness of their Quality Management System and for meeting all regulatory requirements.
Describe your device idea. VitaQMS returns a rule-based classification preview across FDA, EU MDR, and CDSCO — instantly, no account needed. Every result is orientation only; your qualified regulatory team still owns the final call.
Fill in the form and hit Preview classification to see FDA, EU MDR, and CDSCO candidate classes.
Most medical-device teams run their QMS in one tool, their eCRF in another, their risk file in a spreadsheet and their clinical evidence in a shared drive. It leaves gaps that Notified Bodies and the FDA find every single time.
ISO 13485, FDA QMSR (2026), EU MDR/IVDR, MDSAP, IEC 62304, ISO 14971, ISO 14155, IEC 62366 — plus the EU AI Act and cybersecurity for AI-enabled devices. Each with different evidence templates.
Duplicate entry, version conflicts, incomplete Design History Files, findings that never make it back into the risk file. Clinical results end up outside the QMS.
Days lost pulling exports from four systems, praying the versions line up. One-click evidence packages? Not without a platform that knows every regulation.
EU AI Act high-risk, FDA predetermined change control plans, GMLP, IEC 62304 lifecycle — most QMS tools weren't built for continuously-learning models.
Regulators increasingly expect structured patient advisory input, preference studies, and human-factors validation. Word docs and inbox threads don't satisfy that.
A change in a component or a firmware release should surface every affected clinical study, risk control and jurisdictional filing — automatically.
Enter your intended use. VitaQMS suggests candidate device classifications for FDA, EU MDR, India CDSCO and MDSAP with rationale and applicable rules — for review and confirmation by your regulatory team. Powered by Claude Sonnet 4.5.
Ready-to-review SOP scaffolds, risk file structure, and DHF sections mapped to ISO 13485 and 21 CFR Part 820 — customize under your quality process.
Live polling of FDA, EU EMA and CDSCO feeds. Severity-tagged. Guidance signals for your team's review.
Stripe-powered subscriptions with tax handling in 80+ countries. Optional 2FA. Session security with cookies + JWT. No card data on our servers.
Import device data, sensitivity/specificity metrics and clinical validation results directly from the VitaCyt point-of-care platform. One-click seed for classification review and QMS scaffolding.
Try the demo projectVitaQMS provides AI-assisted templates, document generation support, and workflows to help medical device companies develop elements of their Quality Management System. All AI-generated content must be reviewed and approved by qualified personnel under your own quality processes.
You remain solely responsible for system validation, process suitability, training, and compliance with FDA, EU MDR, MDSAP, CDSCO, and all other applicable regulations. Use of this platform does not guarantee regulatory approval or inspection readiness.
VitaQMS connects with VitaCen.Health and VitaCyt data pipelines to give you a single audit-ready compliance thread — from bench to submission.
Start free. Upgrade to Pro when your workflows are ready. India + US billing supported.
VitaQMS is invite-only during the beta so we can work closely with founding customers. Tell us who you are, get the full white paper immediately, and we'll follow up within one business day with an access code.