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SRI Surgical: Efficiency. Delivered Daily. - SRI Surgical’s state-of-the-art, FDA-regulated, service centers provide daily processing, assembly and delivery of all the reusable and disposable products and instruments required for surgery. This innovative capability establishes a new benchmark for hospital efficiency and OR productivity.
SRI Surgical FDA Compliance - All equipment and procedures at our 10 processing facilities are FDA-regulated, requiring rigorous inspection processes to ensure that federally recommended guidelines are followed. These controls offer our customers the highest degree of quality assurance and service consistency.
FDA Compliance: All regulated processes are designed to comply FDA Quality Systems requirements FDA Compliance: SRI Service Centers are FDA registered and are subject to regular inspections.
         
 

FDA Compliance

All equipment and procedures at our 10 processing facilities are FDA-regulated, requiring rigorous inspection processes to ensure that federally recommended guidelines are followed. These controls offer our customers the highest degree of quality assurance and service consistency.

  • Instrument & Stainless processing meets standards in AAMI TIR 12-2004 and ANSI/AAMI ST35-2003.
  • Sterilization process meets or exceeds ANSI/AAMI/ISO 11134, AAMI TIR No. 13, AAMI ISO 11737-2, ISO 13683 and AAMI ST46.
  • All regulated processes are designed to comply FDA Quality Systems requirements 21 CFR Part 820.
  • All reusable barrier products are processed per ANSI/AAMI ST65.
  • Liquid proof barrier gown (PPE) products meet or exceed requirements in ASTM F1671.
  • Liquid proof barrier drape products meet or exceed requirements in ASTM F1670.
  • SRI Service Centers are FDA registered and are subject to regular inspections.
  
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