AI Powered QMS for Medical Device Manufacturers
An end-to-end quality system from raw material to finished product. Trace every lot, sign every record, and stay ready for CDSCO, ISO 13485, 21 CFR Part 11, and EU MDR.
Trusted by 20+ manufacturers·Full audit trail·E-signatures included
Manufacturers using RapidFacto
Trusted by 30+ medical device manufacturers
Modules
Every module writes to the same lot record. The circle turns through them in order, or select one to see its screen.
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Purchase
Request quotations, approve purchase orders from the supplier list, and receive goods against the order.
Standards we support
The batch record, the SOP, and the signature are the evidence for each of these. You do not keep a separate file for each audit.
Batch manufacturing record
The operator enters dispensing, the in-process check, and the release signature on the line. That entry is the batch manufacturing record you hand to CDSCO. Nobody rebuilds it from a paper book.
- The product model sets the step order, the batch size, and the check expected at each stage.
- Each step records the in-process result, the machine, and who ran it.
- Finished-good testing and the certificate of analysis stay on the same batch.
- The finished lot moves into stores only after that record is complete.
Quality system
Document control
A SOP is drafted, reviewed, and signed before the floor uses it. The document register keeps each procedure in its folder with its current status.
- QA reviews it before it can be released.
- Quality signs it under 21 CFR Part 11. The name, the time, and the meaning stay on the document.
- When the new revision becomes effective, the previous one is marked obsolete.
- People who use the SOP are assigned training on the new revision.
Reports
Batch, material, and training reports
BMRs, material inspection, purchase orders, and training logs, exported as PDFs with the audit trail and the e-signature.
Batch Manufacturing Record
BMR-2026-0312
Audit trail
Linked & signed
Digitally signed · 21 CFR Part 11
Pass
Batch Manufacturing Record·Batch Release Certificate·Finished Good Test Report·Product Transfer Slip·Raw Material Requisition Slip·Raw Material Issuance Record·Packing Material Requisition·Packing Material Transfer·Material Inspection Report·Material Testing Report·GRN Inspection Report·Certificate of Analysis·Material Specification·Purchase Order·Delivery Challan·Sales Invoice·Approved Vendor List·Machine Maintenance Records·Machine Downtime Records·Equipment Logbook·Training Records
Software validation package
We hand over RPF-SVP-001. Your QA team still executes it for your configuration.
Protocols · Traceability matrix · Part 11 assessment · ISO 13485 and IEC 62304 notes
Read the validation packageFAQ
Common questions from medical device manufacturers evaluating RapidFacto.
RapidFacto is a quality management platform built for medical device manufacturers. It covers manufacturing batch records, document control, CAPA, training, purchase, inventory, and post-market surveillance — in one audit-ready system.
RapidFacto is designed for ISO 13485:2016, CDSCO MDR 2017, EU MDR 2017/745, 21 CFR Part 11, and 21 CFR Part 820, with ISO 14971 risk files, IEC 62304 software lifecycle controls, MDSAP, and EU Annex 11. Every action is logged with a full audit trail.
Foundation and Growth are quoted to your user count and sites. An implementation fee applies to every plan, on top of the annual subscription. Scale is scoped for multi-site operations. Contact us and we will send an itemised proposal.
Most customers go live within a few weeks. Setup includes configuration, data migration support, and training for your team. Timeline depends on the complexity of your existing processes.
Yes. RapidFacto is built for audit readiness — versioned documents, e-signatures, batch traceability, and complete audit trails. Manufacturers using RapidFacto have passed ISO 13485 and CDSCO inspections.
Yes. RapidFacto is a cloud platform accessible from any browser. No on-premise installation required. Your data is stored securely with role-based access controls.
Yes. Foundation and Growth both include manufacturing, QMS, purchase, inventory, and post-market surveillance. Plans differ by users, sites, and the level of implementation and support.
Yes. You can export documents, records, and reports at any time. Your data belongs to you — we never lock you in.
Still have questions? Contact us