Medical Device Inspection: Patient Safety First
Validated machine vision systems engineered for medical device manufacturing—ensuring UDI compliance, sterile packaging integrity, implant traceability, and seamless FDA/CE audit readiness.
Traceability from manufacturing to patient care
Meeting Global Medical Device Regulations
Our systems are purpose-built to address the stringent compliance landscape of Class I-III medical devices
🇺🇸 FDA UDI & QSR Requirements
Unique Device Identification mandates and Quality System Regulation for design, manufacturing, and distribution.
- DI & PI code verification (GTIN + serial/lot/expiry)
- Direct marking verification for reusable devices
- GUDID database submission support
- Electronic signatures & audit trails (21 CFR Part 11)
🇪 EU MDR & IVDR Compliance
Medical Device Regulation and In Vitro Diagnostic Regulation requirements for safety, performance, and traceability.
- Basic UDI-DI assignment verification
- EUDAMED registration data linkage
- Clinical evaluation & PMCF documentation support
- Post-market surveillance traceability
🌍 Global Standards
Harmonized approaches for ISO, GHTF, and emerging market regulatory pathways.
- ISO 13485 quality management alignment
- ISO 15223 medical symbols verification
- Sterilization batch & expiry tracking
- Multi-region labeling compliance (US/EU/Asia)
Achieving Zero-Defect Sterile Packaging for Implantable Devices
Challenge: The manufacturer needed to verify UDI codes, sterile barrier integrity, and lot traceability for hip/knee implants while maintaining ISO 7 cleanroom conditions and passing unannounced FDA audits.
- Deployed Unicus Vision UDI verification & sterile packaging inspection systems
- Implemented laser direct marking (LDM) verification with sub-pixel accuracy
- Integrated track & trace with hospital procurement & implant registry systems
- Established validated IQ/OQ/PQ documentation for FDA audit readiness
Medical Device Solutions Portfolio
Validated systems designed for regulatory compliance and patient safety
UDI Serialization Systems
Generate, print, and verify DI/PI codes compliant with FDA UDI, EU MDR, and GUDID/EUDAMED requirements.
Learn more →Medical Label & Packaging QC
Verify ISO 15223 symbols, sterility indicators, expiry dates, and multi-language instructions at line speed.
Learn more →Direct Mark & Code Verification
High-resolution verification of laser-etched UDI on reusable instruments with ISO 15415 grading.
Learn more →Implant & Distribution Traceability
End-to-end tracking from manufacturing to hospital implantation with adverse event reporting linkage.
Learn more →Ensure Compliance. Protect Patients. Pass Every Audit.
Our MedTech specialists will conduct a free UDI gap analysis and validation readiness review against FDA/CE requirements.