Product Highlight

9 good reasons why FOBA is your first choice...

Most of the global players and many small and medium-sized manufacturers of implants, instruments and medical devices rely on us when installing a UDI-compliant marking process. Our commitment to total customer satisfaction as well as worldwide service ensure your sustainable success.

UDI Compliance

  • Support for all regulatorily (FDA, MDR) mandated UDI code formats (bar codes, data matrix codes, etc.)
  • Creation of permanent, resilient, high-contrast UDI marks that ensure full readability even after numerous cleaning cycles and throughout the entire product life cycle


Code Format Reliability

  • HIBC Approved Solution Provider and GS1 Solution Partner
  • Support for most commonly used UDI code designs GS1 and HIBC
  • Code-conformity acc. to the AIM DPM standard (ISO/IEC 15415)


High-Quality Marking

  • Universally applicable laser systems mark the complete variety of medical materials
  • Including 4301 Stainless, Titanium, PEEK, POM, PPSU, etc.
  • Multiple wavelengths (fiber, CO2, UV) for every material request
  • Creation of durable, counterfeit-safe, highly precise sharp-contour characters, machine-readable codes and other formats
  • Autoclavable black-marking for metal medical devices with Y.0201
    • High-contrast marking of sensitive plastics with V.0020-UV
    • Creation of codes that are resistant to sterilization and cleaning processes


Vision Inspection, Code Validation

  • Patented, laser built-in through-the-lens vision system IMP (Intelligent Mark Positioning)
  • 4 pre-mounted, fully software-controllable lightbars allowing for even illumination and reducing unwanted hot spot reflections
  • Pre- and post-mark inspection ensures drastic scrap reduction:
    • Part validation and pre-mark verification prior to marking
    • Automatic mark alignment with IMP
    • Fixtureless marking with patent-pending MOSAIC™ feature
    • Mark verification, code validation and OCV (Optical Character Verification) after marking

 

Closed-Loop Marking Process

  • Vision-guided Holistic Enhanced Laser Process (HELP)
  • Part and mark validation with pre- and post-mark the inspection ensures drastic scrap reduction
  • High-precision automatic mark alignment
  • Only the correct marks are applied to the correct parts on the right position
  • Mark verification and code validation incl. OCV (Optical Character Verification) after marking directly in the marking laser machine


Fixtureless Marking

  • FOBA MOSAIC™ – full-field scanning
    • Automated mark alignment on parts that are loosely placed within the marking field
    • Expensive part fixtures are no longer needed
    • Significant cost savings in production and equipment validation
    • Ease of Use and Integration
    • Advanced Operator Plugin (AOP) ensures a safe and error-free UDI marking process that helps improve production efficiency and facilitate laser marking for users with any skills
    • AOP captures inspection results and provides "Documented Evidence of a Stable Process"
    • Built-in software/ERP interfaces (Majesty, SAP, etc.)
    • Easy adaption to production and data processing environments Technological Expertise
    • 35 years of excellence in the laser marking business
    • Combined experience in medical part marking unparalleled
    • Continuous R&D in vision-assisted laser marking
    • Close insights into the requirements of medical manufacturers
    • Intense cooperation with notified bodies and medical authorities


Worldwide Services

  • Acceptance Packages incl.
    • Factory Acceptance Test FAT and Site Acceptance Test SAT
    • Process Capability Testing (CpK)
    • Machine Qualification
    • Customer-specific end test
  • Customized mechanical and software engineering in order to meet customer-specific requirements and challenges
  • Dedicated lifecycle services incl.
    • Service Care Packages (SCP), IQ, OQ, PQ, MQ
    • Remote diagnostics & system monitoring
    • 24/7 hotline support (depends on SCP)
    • Dedicated global service tech network
    • Global spare parts stocks
    • Local consignment stocks
    • Spare parts availability: min. guaranteed
    • 5 years and up to 10 years on demand
    • On-site customer training
    • IoT data with FOBA Remote Service (FRS)
    • Global application development and on-site support
    • Up to 5 years warranty with SCP

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