SAM #36C25226Q0713

Cleaning Validation Service for Formlabs Surgical Guide Resin Dental Devices

This opportunity is for a specialized cleaning validation service for Formlabs Surgical Guide Resin dental devices at the Clement J Zablocki VA Medical Center. - Government Buyer: - Department of Veterans Affairs - Great Lakes Acquisition Center (Network Contract Office 12) - OEM Highlight: - Formlabs (manufacturer of Surgical Guide Resin) - Vendors/Products/Services: - Cleaning validation service for Formlabs Surgical Guide Resin dental devices - Cleaning agent specified: Enzol - Service includes testing per ANSI/AAMI, ASTM, and FDA guidance - Contractor must hold ISO 17025 accreditation - Deliverable: Detailed written report of validation results - Supplies, protocol, and report included - Quantity: 1 service line item covering 5 devices, 6 cleaning cycles, 3 efficacy cycles, and two endpoint markers (Hemoglobin/Protein) - Unique Requirements: - Service must be performed at contractor's facility - Cleaning validation must use Enzol as the cleaning agent - Testing must comply with ANSI/AAMI, ASTM, and FDA standards - Contractor must be ISO 17025 accredited - Completion required within 120 days after award - Firm fixed price contract for a nonpersonal commercial service

Description

One-time cleaning validation for Formlabs Surgical Guide Resin for Clement J Zablocki VA Medical Center in Milwaukee, WI. Services shall be performed at the Contractor's place of business. Perormance shall be completed within 120 days after date of award.

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