Change Requests

Transition to new anodization supplier

Current anodization supplier (MetalCoat GmbH) announced plant closure Q4 2026. Identified two qualified replacements: TitanFinish AB and SurfacePro Ltd.

Complaint #CLM-0142: Forceps jaw misalignment

Customer complaint: 2 units from Lot 2026-003 showed 0.3mm jaw offset. Production QC sampling plan needs review.

Update biocompatibility test protocol

ISO 10993-1:2025 revision requires updated cytotoxicity and sensitization testing for devices with prolonged skin contact.

Add UDI-DI barcode to secondary packaging

EU MDR Article 27 compliance deadline approaching. All Class IIa devices must have UDI carriers on packaging by Q3 2026.

CAPA #2024-017: Supplier lot traceability gap

Internal audit finding: titanium supplier Lot IDs not consistently linked in incoming inspection records. Root cause: manual entry errors in the ERP system.

Redesign scalpel handle grip pattern

Ergonomic field feedback from 3 surgical centers indicates grip fatigue during prolonged procedures. Propose textured silicone overmold redesign.

Update sterilization parameters for SF-200

New EU MDR requirements mandate updated sterilization validation for Class IIa surgical instruments. Bioburden testing results suggest cycle parameters need adjustment.