Automated inspection systems for regulated manufacturing where conventional machine vision falls short. Selected examples from our delivered work:
Multi-year optical inspection program for transparent contact lens molds: angle-of-attack illumination, refraction, and light scatter for translucent defect detection, plus second-generation system, architecture redesign, automated cosmetic inspection upgrade, enclosure design, emissions compliance, and operator training.
CAPA-driven automated inspection for shoulder, knee, and hip implants with uncertainty analysis, Measurement System Analysis (MSA), and an in-situ process gauge, with test method V&V per 21 CFR 820.70(i).
Camera-based test system, LabVIEW test software, and a hardware abstraction layer validating breath alcohol detection, vehicle interface communication, and tamper detection on court-ordered breathalyzer devices.
Designed a new test set that uncovered latent false positives on a device that had been passing manufacturing tests for years, redirecting engineering from test redesign to product failure analysis. Test method V&V per 21 CFR 820.72(a).
Contact lens mold inspection system using angle-of-attack illumination, refraction analysis, and light scatter for translucent defect detection. Multi-year engagement from R&D through production deployment with enclosure design, emissions compliance, and operator training.
CAPA-driven automated inspection for a Class II orthopedic implant manufacturer producing shoulder, knee, and hip implants, with uncertainty analysis, Measurement System Analysis (MSA), and in-situ process gauge design. Plus a camera-based test system for an automotive ignition interlock device manufacturer.
Production-grade inspection systems with full V&V documentation, MSA studies, uncertainty budgets, and integration with quality management systems for 21 CFR 820.70(i) compliance.
Custom illumination design including angle-of-attack lighting, refraction analysis, and light scatter for transparent and translucent materials. Used on the contact lens mold inspection system to detect surface defects and occlusions in transparent contact lens molds.
In-situ process gauge design for production inspection, plus mechanical enclosure design and operator training. Emissions compliance engineering support delivered alongside the contact lens mold inspection system equipment.
Image-based defect detection on materials that defeat conventional machine vision, plus the kind of measurement uncertainty work needed to redirect engineering when test systems mask real product failures. Demonstrated in a Class II medical device engagement that uncovered latent false positives passing manufacturing tests for years.
We build production-grade inspection systems with the optical engineering, measurement science, and regulatory documentation your quality system requires.
R&D Through Production
We engage from feasibility studies and optical concept development through production deployment, operator training, and sustained support.
Quality System Integration
We work within your quality management system from day one, delivering MSA studies, uncertainty documentation, and V&V packages alongside the inspection hardware.
CAPA-Driven Development
When inspection systems are driven by corrective actions, we structure the engineering to satisfy both the technical requirements and the regulatory documentation trail.
We build to the quality and regulatory standards your manufacturing environment requires. Touchpoints from our delivered work include 21 CFR 820.70(i) non-product software verification and validation, 21 CFR 820.72(a) calibration and Measurement System Analysis, test method verification and validation, and CAPA-driven engineering on FDA-regulated inspection deployments.
We build production-grade inspection systems with the optical engineering, measurement science, and regulatory documentation your quality system requires.
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