Solutions
Software for how a device plant actually works
Not a generic QMS with a medical-device skin. Batch records, documents, design, and incoming QC — the work you already do, in one system.
Manufacturers using RapidFacto
Trusted by 30+ medical device manufacturers
Who we build for
Medical devices
RapidFacto is written for device manufacturers — not generic life-science software with a medical-device checkbox. Batch records, incoming QC, DHF, and CDSCO paperwork sit in the same system your production team already uses.
The move off paper
Paper to digital
Most plants we meet still run BMR in a printed book and quality in shared folders. RapidFacto replaces that stack — not with another spreadsheet, with the same workflows your people already know.
The standard
ISO 13485
ISO 13485 is not a document library. It is document control, design, purchasing, production, CAPA, and management review — linked. RapidFacto is built around those processes, not around folders.
India MDR 2017
CDSCO inspections
CDSCO walks the floor. They ask for the BMR, the incoming inspection, the training record, and the last CAPA. RapidFacto keeps those on the batch and the product — not in a cupboard labelled “audit”.
Electronic records
21 CFR Part 11
Part 11 is not a checkbox on a quote. It is unique users, re-authentication at sign-off, a manifestation of the signature, and an audit trail that cannot be quietly edited.
When they arrive
Audit readiness
Readiness is not a war-room the week before. It is the BMR, the DHF, the CAPA, and the training file already matching what happened on the line. That is what RapidFacto stores as you work.