Stop Recalls Before They Start. AI Vision for Medical Device QC.
Catch defects your current system misses. Stay FDA-compliant without the paperwork headache. Get back to what matters—shipping quality devices.
Why Manufacturers Choose Us
Your FDA Audit
Starts Here
You need inspection systems that work when the FDA walks in—not promises that fall apart under scrutiny.
Our vision systems are built for real cleanrooms, real audits, and real production pressure. Complete 21 CFR Part 11 traceability, automated documentation, and U.S.-based support when you need it.
FDA Compliant
21 CFR Part 11 ready
Cleanroom Ready
ISO Class 7 compatible
Proven Precision
micro-defect detection
What We Inspect
Every Step. Every Device. Zero Guesswork.
UDI & Label Verification
Tired of manual label checks slowing down your line? Our AI reads UDI codes, lot numbers, and expiration dates instantly—flagging errors before they become FDA warning letters. One less thing to worry about.
Micro-Defect Detection
Your inspectors can't catch what they can't see. Our AI spots surface scratches, contamination, and dimensional issues on surgical tools and implants that human eyes miss. Protect patients. Protect your reputation.
No Retraining Required
Switching SKUs shouldn't mean days of system downtime. Our adaptive AI handles blister packs, vials, and syringes without constant retraining. Add new products to your line without adding new headaches.
High-Speed, Zero-Damage Sorting
Delicate components deserve careful handling. Our vision-guided sorting keeps your line moving fast while treating every catheter, stent, and implant like the precision instrument it is.
3D Measurement & Fit Verification
When millimeters matter, you need more than a camera. Our 3D measurement catches curvature issues, surface deviations, and fit problems that 2D inspection can't detect. Because "close enough" isn't good enough for medical devices.
Sterile Barrier & Seal Integrity
A compromised seal means a compromised product—and a potential recall. Our vision systems verify every sterile barrier before it ships, catching seal failures and contamination risks that put patients at risk.
Sound Familiar?
These are the problems we hear from medical device manufacturers every week. If you're dealing with any of these, we should talk.
"Our cameras keep fogging up in the cleanroom."
Standard cameras weren't built for your environment. Ours are—sealed optics, anti-fog coatings, and zero condensation issues.
"We found defects after shipping. Again."
If defects are slipping through, your inspection isn't working. Our AI catches what human inspectors miss—before products leave your facility.
"Preparing for audits takes weeks."
Stop scrambling before FDA visits. Our systems auto-generate 21 CFR Part 11 compliant audit trails and reports—ready when you need them.
"We're throwing away good product."
High false-reject rates kill your margins. Our AI distinguishes real defects from acceptable variation—so you keep what you should keep.
"Every new product means system downtime."
Adding new SKUs shouldn't stop production. Our adaptive AI learns new products quickly—often in hours, not days.
"When something breaks, we wait days for help."
Production problems can't wait for overseas support. Our U.S.-based team responds within hours—because your line shouldn't be down waiting.
Smarter Vision Systems for Modern Manufacturing and MedTech
Get Started with OspreyX
Full-stack machine vision, engineered for real-world factories — not research labs.
High Accuracy from Day One
Solution Design
Transparent Pricing & Specs
Live Demo