ISO 13485:2016 & MDSAP Certified Laboratory

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.

40+
Years of Industry Experience
ISO
13485:2016 & MDSAP Certified
90+
Years Combined Lab Expertise
72hr
Decon Turnaround Objective

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.

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Sterilization Validation

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.

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Reusable Medical Device Validation

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.

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Medical Device Decontamination

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.

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Contract Packaging

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.

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Environmental Monitoring

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.

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C.G. Laboratories ISO-certified microbiology laboratory facility in Granbury, Texas
40+
Years Trusted Expertise

More Than a Testing Lab — Your Compliance Partner

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.

Discover Our Story

ISO 13485:2016 & MDSAP Accreditation

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.
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.
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.
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.

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

End-to-End Partnership

  • Concept-through-distribution contract manufacturing
  • Package, sterilize, test, validate & shelf-life studies
  • Hydrogel formulation, production & packaging
  • Consulting for cleanroom & facility validation
  • External laboratory or one-time service flexibility

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."

— Contract Packaging Customer