Precision Testing. Trusted Validation. 40+ Years of Excellence.
C.G. Laboratories delivers rigorous medical device testing, sterilization validation, and compliance solutions for manufacturers worldwide — where service and guidance never stop.
Comprehensive Medical Device Testing & Validation Services
From sterilization validation to environmental monitoring, our ISO-certified laboratory delivers end-to-end compliance solutions that get your devices to market safely and efficiently.
Laboratory Testing Department
Our ISO 13485:2016 certified microbiology laboratory offers bioburden testing, sterility testing, bacteriostasis/fungistasis validation, endotoxin testing, and more — with over 90 years of collective team expertise serving the medical device industry.
We are a recognized leader in medical device sterilization validation — covering ethylene oxide, steam, and E-Beam sterilization processes — ensuring full FDA and ISO regulatory compliance for sterile device manufacturers.
Comprehensive validation and development of Manufacturer's Instructions for Use (IFU) for reusable medical devices, including washer disinfector validation and automated cleaning consultation to ensure safe reprocessing.
Tailored decontamination and sterilization services for complaint devices, with customizable processes for specific device specifications. Our operational TAT performance consistently exceeds our 72-hour objective for rapid turnaround.
Turn-key contract packaging services for sterile medical devices and non-sterile products, including sealing validation, packaging integrity testing, hydrogel contract packaging, and full shelf-life studies to market readiness.
Proactive environmental monitoring programs for manufacturing facilities and cleanrooms — including air microbial monitoring, surface sampling, cleanroom disinfection validation, and particle counter services to maintain GMP compliance.
Founded in 1983 by Dr. Glenn Crum, C.G. Laboratories began as a microbiology laboratory and has grown into a multi-service company with three distinct divisions spanning 19,000 square feet across two sites in Granbury, TX. We are FDA-registered and hold ISO 13485:2016 and MDSAP accreditations. Our scientists work directly with you — human-to-human — to solve complex regulatory and scientific challenges, guiding you from concept through distribution.
Our laboratory is fully accredited to ISO 13485:2016 and MDSAP (Medical Device Single Audit Program), ensuring our quality management system meets the highest international standards for medical device manufacturing support.
FDA Registration & Regulatory Compliance
C.G. Laboratories is registered with the FDA, providing clients with the regulatory confidence needed for product submissions and market clearance. Our consulting team assists with FDA compliance strategies, validation protocols, and submission documentation.
CLIA Certified & Multi-Industry Capability
Holding CLIA certification alongside our ISO accreditation, we serve the medical device, tissue, dental, and life sciences industries. Our 19,000 sq ft dual-site facility supports full-service laboratory testing, contract manufacturing, and packaging operations.
90+ Years Combined Scientific Expertise
Our laboratory team collectively holds over 90 years of hands-on experience in microbiological analysis, sterilization science, and regulatory testing. Expedited services are available for time-sensitive client needs with responsive, personalized support.
Why CG Labs
The Competitive Advantages of Choosing C.G. Laboratories
Our scientists work with you, human-to-human, offering customization and comprehensive solutions at every stage. Our service and guidance never stop.
Proven Regulatory Expertise
FDA-registered facility with MDSAP accreditation
ISO 13485:2016 quality management system
Expert FDA compliance consulting services
AAMI, ISO 11135, ISO 11137, ISO 15883 standards
Validation protocol development & execution
Rapid Turnaround & Reliability
72-hour decontamination TAT objective consistently met
Expedited laboratory testing services available
Responsive customer service — no task too small
Direct scientist-to-client communication model
Integrated data processing & documentation options
External laboratory or one-time service flexibility
Client Testimonials
What Our Clients Are Saying
Don't take our word for it — hear directly from the medical device manufacturers and healthcare companies who rely on C.G. Laboratories every day.
"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."
— Decontamination Customer
"No task is too small. They make us feel as if I'm their only customer… if they aren't able to provide an answer at the time of the call, they will get with me ASAP."