Documented information
Versioned SOPs, records, and obsolete control. Review before issue. Training on the effective rev.
The standard
Run the clauses you will be asked about
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.
Manufacturers using RapidFacto
Trusted by 30+ medical device manufacturers
Design and development
User needs, inputs, outputs, V&V, risk, and DHF on the product — then transfer into manufacturing.
Purchasing and production
Approved vendors, incoming inspection, lot traceability, and batch release with the signatures the clause expects.