FDA Reprocessing Guidance • ISO 17664 • ANSI/AAMI ST98 • AAMI TIR12 • AAMI TIR30
C.G. Laboratories, Inc. specializes in the validation and development of Manufacturer's Instructions for Use (IFU) for reusable medical instruments and equipment. Per FDA regulations and international directives (such as EU MDR 2017/745), medical device manufacturers bear sole responsibility for scientifically validating all cleaning, disinfection, and sterilization instructions provided to healthcare facilities.
Improper reprocessing instructions can lead to bio-burden accumulation, residual protein contamination, cross-infection risks, or material degradation. Our multidisciplinary scientific team guides overseas manufacturers through every phase of reprocessing validation, ensuring your labeling claims are fully supported by empirical microbiological data before submitting to regulatory authorities.
Our ISO 13485:2016 accredited testing facility evaluates all parameters required by healthcare reprocessing protocols, ensuring patient safety and instrument longevity.
Assesses the destruction of resilient biological indicators (e.g., Geobacillus stearothermophilus) using moist-heat steam autoclaving cycles under half-cycle and full-cycle parameter challenges.
ANSI/AAMI ST79 & ISO 17665Evaluates low-temperature Hydrogen Peroxide Vapor / Gas Plasma sterilization efficacy for heat-sensitive or moisture-sensitive reusable endoscopic and surgical instruments.
Vaporized H₂O₂ ProtocolsValidates manual scrubbing, soaking, and ultrasonic cleaning procedures by quantifying residual soil levels, specifically protein and hemoglobin markers post-cleaning.
AAMI TIR30 & FDA ReprocessingEvaluates washer-disinfector automated cleaning efficiency using artificial blood soil, mucin, and tissue soil matrices to confirm automated cycle compliance.
ISO 15883 CompliantVerifies log-reduction of vegetative bacteria, mycobacteria, viruses, and fungal spores across low, intermediate, and high-level chemical disinfection processes.
EPA & FDA Efficacy CriteriaExposes medical devices to repeated cleaning, disinfection, and sterilization cycles (up to continuous maximum lifetime limits) to verify physical, thermal, and functional integrity.
Endurance & Biocompatibility
Founded in 1983 by Dr. Glenn Crum, C.G. Laboratories has evolved into an international reference facility operating 19,000 square feet of specialized testing and contract manufacturing space across two sites in Granbury, Texas, USA.
Our quality management system is audited and certified to global standards, assuring regulatory acceptance in North America, Europe, Asia-Pacific, and Latin America.
Direct access to seasoned microbiologists and regulatory engineers with over 90 years of combined laboratory experience, guiding your IFU validation from protocol design to 510(k) approval.
Identifying cleaning or material failure points prior to commercial submission prevents costly FDA hold letters, product recalls, and international distribution delays.
A transparent, scientifically rigorous protocol designed to withstand scrutiny from global health authorities.
Review device design, material compatibility, intended clinical use, and target regulatory markets to define validation scope.
Draft tailored validation protocols referencing FDA reprocessing guidance, AAMI TIR12, AAMI TIR30, and ISO 17664 standards.
Inoculate devices with standardized biological soil (artificial blood/mucin) and microbial challenges to simulate worst-case clinical contamination.
Perform quantitative protein, hemoglobin, TOC, and bioburden assays alongside sterility and functional verification.
Deliver comprehensive, audit-ready technical report packages formatted directly for FDA 510(k), CE Mark, and MDSAP filings.
Key technical insights for quality leaders and regulatory managers preparing device validation submissions.
Partner with C.G. Laboratories for audit-ready reusable medical device validation reports that satisfy FDA, MDSAP, and EU MDR compliance demands.
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