Delivering Excellence in Medical Device Manufacturing
CGI Inspection partners with medical device manufacturers to deliver precision inspection of the components that matter most — implants, surgical instruments, housings, and diagnostic device parts. Our team understands the compliance demands of medical production, where dimensional accuracy directly affects patient safety and regulatory approval. We bring proprietary scanning technology and metrology expertise to every engagement, helping you achieve zero-defect production and faster time to market.
Why Partner with CGI Inspection?
The medical device space demands more than just precise measurements — it requires an inspection partner with deep regulatory knowledge, validated processes, and the technology to match. Our certified engineers have worked across FDA-regulated environments and understand what it takes to produce inspection documentation that supports submissions and withstands audits. We don't just hand you data — we help you understand what it means and ensure your parts are ready for approval.
Key Challenges
Medical device manufacturers face relentless pressure to achieve zero-defect production within strict regulatory timelines. The intricate internal geometries of modern implants, housings, and surgical components make traditional contact-based metrology slow and inadequate. A single dimensional deviation can trigger an FDA hold, force costly recalls, or compromise patient outcomes. Companies need a metrology partner with both the technical precision and regulatory understanding to move fast without cutting corners.
Our Approach
Our approach combines the Pearl-700 Desktop 3D Scanner with Spec.Check software to deliver a complete, non-destructive dimensional inspection of your medical components. We digitize every surface and internal geometry in a single high-resolution scan, compare the physical part directly against your CAD model, and generate a comprehensive first-article inspection report with a full dimensional audit trail — formatted and ready for FDA and ISO regulatory submission. Our team works alongside your quality engineers from the start to define critical inspection points and ensure every deliverable is actionable.
Every report we produce includes a complete deviation map, GD&T callout analysis, and a digital record that supports your internal quality system. Whether you're preparing for a first article submission or conducting ongoing production audits, CGI Inspection provides the data clarity and documentation you need to move forward with confidence.
Our Commitment
- Regulatory-Ready Reports: Every inspection report is structured to support FDA submissions, ISO 13485 audits, and first-article approval packages.
- Non-Destructive Inspection: Our non-contact scanning preserves part integrity while capturing every internal and external feature — no damage, no compromise.
- ±0.0008 Inch Accuracy: Our measurements meet and exceed the dimensional tolerances required for Class II and Class III medical device components.
- End-to-End Quality Partnership: From initial part intake through final inspection reporting, our certified engineers are embedded in your quality process at every step.
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