UDI and Laser Parts Marking in the Medical Industries → 9 good reasons to choose FOBA laser marking solutions We are proud to say that 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 branches and essential services such as remote maintenance or on-site trainings ensure your sustainable success. Fixtureless Marking Worldwide Services → 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 ⊲ 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 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) → 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 ⊲ Acceptance Packages incl. → Factory Acceptance Test FAT and Site Acceptance Test SAT → Process Capability Testing (CpK) → Machine Qualification → Customer specific end tests ⊲ 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 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 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 in the requirements of medical manufacturers Intense cooperation with notified bodies and medical authorities 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 Customer Database UDI Laser Marking Solution Closed-Loop Marking Process ⊲ Vision-guided Holistic Enhanced Laser Process (HELP) → Part and mark validation with pre- and post-mark inspection ensure 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 Software – Vision – Workflow Post-Mark Inspection → mark verification → code reading and validation → OCV Pre-Mark Inspection → part validation → pre-mark verificat