ISO 13485:2016 & MDSAP Accredited Laboratory

About C.G. Laboratories, Inc.

Where Service and Scientific Guidance Never Stop — Over 40 Years of Excellence in Medical Device Testing & Sterilization Validation

C.G. Laboratories testing facility in Granbury Texas featuring modern cleanroom microbiology equipment
19,000 Sq. Ft. Facility Dual-Site Complex in Granbury, TX

Get More With C.G. Laboratories

Completely automated processes provide value, but medical device compliance requires tailored scientific consultation. Our multidisciplinary team of microbiologists and regulatory engineers work directly with international medical device manufacturers, human-to-human, to overcome regulatory hurdles and solve intricate quality challenges.

From initial device development through market release, we offer customization, precise protocols, and continuous support. We don't just deliver test results — we provide expert guidance that helps global life sciences companies achieve compliant market clearance quickly and confidently.

Three Core Operating Divisions

C.G. Laboratories operates three fully integrated divisions designed to provide turn-key testing, sterilization, and contract manufacturing for global medical device and life science procurement officers.

01

Microbiology Laboratory

Serving the medical device, tissue, orthopedic, and dental industries as a premier external testing laboratory or on a one-time project basis. Equipped for regulatory compliance testing under stringent global standards.

  • Bioburden testing & microbial determination
  • Product sterility testing & B/F validation
  • Bacteriostasis / Fungistasis validations
  • Chromogenic endotoxin LAL testing
  • Dialysis water & environmental monitoring
02

Decontamination & Sterilization

Rapid processing of complaint medical devices and custom decontamination procedures engineered to exact client specifications. Optimized for high operational efficiency and quick turnaround times.

  • Consistently exceeds 72-hour TAT target
  • Customizable device decontamination protocols
  • Integrated electronic documentation & processing
  • Ethylene Oxide (EO) sterilization validation
  • Steam & E-Beam process validation
03

Contract Manufacturing & Packaging

End-to-end manufacturing solutions taking single-use and reusable devices from initial concept to commercial packaging, sterilization, and global distribution readiness.

  • Hydrogel formulation, production & packaging
  • Sealing validation & package integrity testing
  • Real-time & accelerated aging stability studies
  • Cleanroom assembly & pouching solutions
  • Complete turn-key market distribution support

Over Four Decades of Scientific Leadership

Founded in 1983 by Dr. Glenn Crum as a dedicated microbiology laboratory, C.G. Laboratories relocated to Granbury, Texas in 1996 to expand into medical device contract manufacturing and validation. Today, our 19,000 sq. ft. dual-site operational hub serves B2B clients across North America, Europe, Asia, and global medical markets.

1983
Year Founded by Dr. Glenn Crum
19,000
Sq. Ft. Dual-Site Texas Facilities
90+
Years Combined Lab Expertise
100%
Audit Success & ISO Compliance

Global Regulatory Certifications & Standards

Our Quality Management System maintains strict alignment with internationally recognized regulatory standards. We undergo continuous auditing to guarantee total data integrity and compliance for our global medical device partners.

ISO 13485:2016 MDSAP Accredited FDA Registered CLIA Certified ISO 11135 / ISO 11137 ISO 15883 Compliance
Laboratory technician performing microbiological testing inside sterile hood at C.G. Laboratories

Partner With a Trusted US Testing & Validation Laboratory

Seeking reliable bioburden testing, sterilization validation, or hydrogel manufacturing for your overseas medical device exports? Speak directly with our technical team today.

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