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

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