A medical device configurator lets manufacturers offer configurable device options, sterile and non-sterile variants, and accessory kits while preserving FDA and ISO 13485 traceability on every order. Sell variety without compromising design control, validated combinations, or your audit trail.
Only validated, compliant combinations can be ordered
Offer size, length, connector, power, and feature options against a controlled rules engine so customers only see cleared, compatible combinations.
Each configuration links to controlled part records and produces a versioned, locked BOM with a full audit trail supporting design history file requirements.
Sterility is a controlled attribute driving packaging, labeling, shelf-life, and validated sterilization method, with incompatible pairings blocked automatically.
Build procedure kits from compatible, cleared accessories and disposables, each carrying its own UDI and lot-control attributes for downstream labeling.
Configured devices generate UDI-ready BOMs and labeling data, keeping unique device identification consistent from quote to shipment.
Option rules are version-controlled, so when a part or clearance changes, every future configuration reflects the approved revision instantly.
Speed and compliance in the same workflow
Sales can configure complex device variants without waiting on regulatory or engineering review of every combination.
Compatibility and clearance rules block configurations that fall outside what is validated and cleared for sale.
Every configured order carries a complete, time-stamped trail, simplifying internal and external audits.
Locked BOMs flow into ERP and MES systems without re-keying or interpretation.
Connect device configuration to quality and production systems
If you are new to the category, see what a product configurator is and what CPQ software does before evaluating for regulated devices.
See how Ignitionary keeps sterile, accessory, and option configurations compliant and fully traceable.