Formlabs Surgical Guide Resin Cleaning Validation

The Department of Veterans Affairs (Clement J. Zablocki VA Medical Center, Milwaukee, WI) requires a third‑party laboratory to perform a cleaning validation on Formlabs Surgical Guide Resin‑based dental drill guides. The contractor will receive up to five devices, develop and execute a test plan (approved by the VA), conduct validation per ANSI/AAMI ST98, ASTM F3293, ASTM F3208, AAMI TIR12, AAMI TIR30 and FDA reprocessing guidance, and provide a comprehensive written report (facility details, study design, results, deviations, compliance statement). ISO 17025 accreditation is mandatory. Work is performed off‑site and must be completed within 120 days of award. Deliverables are submitted electronically to the VA contact. • Off‑site laboratory testing of 3‑D‑printed resin guides • Validation per multiple industry standards • Required ISO 17025 accreditation • Final report with data tables, methods, and compliance sign‑off • 120‑day performance window • No on‑site VA access required