Hand-inspected in Woodstock, Illinois.

Process integrity from the ground up.

Manufacturing happens at one facility, by people who own the result. The same team that builds the equipment also handles calibration, packaging, and shipping. Every step is documented, every batch traceable, every unit identifiable to the operator who built it.

Quality management

ISO 13485:2016 certified quality management system covering design controls, supplier management, manufacturing process validation, packaging integrity, and post-market surveillance. External audits conducted annually by a notified body. Quality documentation packages, including Certificates of Conformance per batch, available for sponsor evidence files within five business days of request.

FDA registration

Active medical device manufacturer registration with the FDA. Registration number provided in regulatory submissions and supplier qualification packages. Annual establishment registration renewal completed without lapse since establishment.

Calibration

Every instrument calibrated against NIST-traceable standards before shipment. Calibration procedures documented and available on request for sponsor regulatory teams. Illumination cabinets ship with a calibration card and documented quarterly check procedure for site technicians. Annual professional service available for clinical practice users.

Hand inspection

Every unit inspected by hand before it ships. Standard policy since 1965. The same standard for a single chart shipped to a private practice and for a 47-site clinical trial deployment. Defects flagged at inspection are reworked or rejected — never shipped with disclaimers. Inspection records archived with the manufacturing batch record.

Documentation available on request

Per-batch Certificate of Conformance signed by quality and traceable to the batch manufacturing record. Material Safety Data Sheets where applicable. Supplier qualification questionnaires (completed) for sponsor procurement teams. Counterfeit reporting procedures published for distributors and end customers. Annual external audit reports available to qualified parties under appropriate confidentiality terms.

Process integrity over volume

We deliberately don't scale through outsourcing. Every chart, every illuminator, every accessory is produced at our Woodstock facility. The team that builds the equipment also handles QA, packaging, and shipping. Decisions about process changes go through quality, not marketing or sales.

This is slower than alternatives. It's also why our endpoint variance data and regulatory acceptance position remain unchanged decade after decade. The standard holds because the process holds.