Microbiology Laboratory Testing
ISO 13485:2016 accredited testing services including bioburden determination, product sterility testing, bacteriostasis/fungistasis validation, chromogenic endotoxin testing (LAL), and AAMI quarterly dose audits.
ISO 13485:2016 & MDSAP Certified Laboratory
Where Service and Guidance Never Stop
Delivering high-precision microbiological testing, sterilization validation, and comprehensive regulatory support for global medical device manufacturers.
Uncompromised Quality & Precision
Your Trusted US Scientific & Regulatory Compliance Partner
At C.G. Laboratories, Inc., we understand that launching medical devices into global markets requires rigorous technical execution and direct, collaborative scientific guidance. Fully registered with the US FDA and accredited to ISO 13485:2016 and MDSAP standards, our Granbury, Texas facility serves international healthcare brands, OEM manufacturers, and tissue banks.
Unlike fully automated lab providers where support ends with a static report, our veteran microbiologists work directly with your QA/RA teams human-to-human. We guide you through protocol development, complex validation execution, and regulatory submission audit requirements.
Key Laboratory Credentials
Serving international procurement requirements with audit-ready documentation, verified protocols, and direct expert communication.
40+ Yrs
Established Industry Heritage
90+ Yrs
Combined Team Expertise
19,000 ft²
Dual-Site Texas Facilities
≤ 72 hrs
Decontamination TAT Target
End-to-End Solutions
Turnkey Medical Device Testing & Packaging Capabilities
We deliver integrated, end-to-end support that accelerates time-to-market while guaranteeing strict adherence to international regulatory frameworks.
Sterilization Validation
Industry-leading validation programs covering Ethylene Oxide (EO per ISO 11135), Steam Sterilization, and Electron-Beam (E-Beam per ISO 11137) dose determination to ensure global sterility assurance levels (SAL 10⁻⁶).
Medical Device Decontamination
Tailored decontamination and sterilization for device complaint returns and evaluation processing. Operating under a reliable 72-hour turnaround objective with complete system data processing integration.
Contract Packaging & Hydrogels
Turn-key contract manufacturing and packaging for sterile and non-sterile devices. Services include pouch sealing validation, packaging integrity testing, hydrogel formulation, and full accelerated shelf-life stability studies.
Reusable Device Validation
Validation of Manufacturer's Instructions for Use (IFU) for reusable surgical instruments, ISO 15883 washer-disinfector qualification, biological indicator assays, and automated cleaning process consulting.
Environmental & Cleanroom Monitoring
Proactive environmental control programs for medical device cleanrooms, including air microbial sampling, surface bioburden analysis, disinfectant efficacy validation, particle counter services, and water safety testing.
Regulatory Excellence
Global Regulatory & Quality Compliance Standards
Our testing protocols and laboratory quality management system strictly conform to international medical device standards required by US FDA, European CE Mark (MDR), and global health authorities.
ISO 13485:2016
Quality Management Systems for Medical Devices
MDSAP Certified
Medical Device Single Audit Program Clearance
FDA 21 CFR Part 820
US FDA Quality System Regulation (QSR) Compliant
AAMI / ISO 11135 & 11137
Ethylene Oxide & Radiation Sterilization Standards
Proven Industry Reputation
Trusted by Global Medical Manufacturers
Our long-standing partnerships with clients stand as proof of our commitment to technical accuracy, responsiveness, and scientific integrity.
"Your facility and work ethics are of the highest standards in the world, and I do and have recommended CG Labs to everyone who asks for reliable sterilization validation and microbiology testing."
— Medical Device Decontamination Client
"No task is too small for C.G. Labs. They make us feel as if we are their only customer. Whenever complex regulatory questions arise, their senior scientists respond immediately with solutions."
— Contract Packaging & Manufacturing Client
Ready to Discuss Your Testing & Validation Requirements?
Connect with our expert team today for customized testing protocols, regulatory consultation, or prompt price estimates for your medical device products.
Contact Us