Decontamination

Medical devices used in surgeries or other procedures (in the field) are the subject of a complaint, are required to be rendered safe for evaluation.

All medical device companies need a Decontamination facility they can depend upon to offer quick, quality driven services. C.G. Laboratories understands that the clock begins ticking the minute a complaint is submitted. We are ISO 13485:2016/MDSAP certified with fully trained technicians to safely decontaminate your contaminated devices.

C.G. Laboratories offers numerous types of decontamination services to fit your device specifications. In house validations are performed to support the decontamination method. We are experts in both!

Why Decontaminate?

  • Your Staff Safety – to render your devices safe to [erform post-use investigation

  • Regulatory Requirements – the FDA requires medical device manufacturers to have procedures in place for receiving, investigating, and evaluating complaints

Over 50% of warning letters issued by FDA to Medical Device manufacturers relate to complaint-handling deficiencies. Many of which are due to inadequate procedures for receiving, investigating, and evaluating complaints.

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C.G. Laboratories, Inc.

(817) 279-1945

Why Choose CG Laboratories? 

C.G. Labs began in 1983 as a microbiology laboratory founded by Dr. Glenn Crum. In 1996, we relocated to Granbury, TX and expanded our services to include medical device contract manufacturing. We have grown into a multi-service company with three distinct divisions with 19,000 square feet spanning two sites. All our services are current, regulated and quality-driven. We are registered with the FDA and ISO accredited to 13485:2016 and MDSAP.

Our GET MORE objective gives you great customer service, guidance, quality management and access to experts. We strive to exceed your expectations, to meet government regulations and to make the world a safer place. With C.G. Laboratories, you always GET MORE.

Why Validate?

  • Compatibility – to confirm that the chosen method is compatible with your device and will not interfere with the investigation
  • Due diligence – confirmation of effectiveness of the method (safe handling), and reduce audit findings exposures
  • Shipping regulations – OSHA, CDC, DoT

Why use C.G. Laboratories?

  • We’ve been a leader in the Decontamination of medical devices since 1998
  • Decontaminated over 1 million devices including hundreds of device families (including electronics and battery powered devices)
  • Fast turnaround times
  • Customizable services including integration directly into your systems, photography, measurements, weight
  • We provide services to all companies, from start-up to fortune 500 companies.
  • CISS (AAMI Certified Sterilization Specialist) on staff

How does it work?

Your contaminated devices (including cadaver trays) can be shipped directly from a hospital or sales representative to C.G. Laboratories. We have all the equipment necessary for decontamination including autoclaves, ethylene oxide sterilizers and biohazard safety hoods (cabinets). Your medical devices, including paperwork, are rendered safe using the appropriate, validated decontamination method. C.G. Laboratories maintains a validated Tracking Software System that monitors each shipment from the moment it arrives until it leaves our facility.

Available Decontamination Methods: (click links below to learn more)

We are experts in developing and validating methods of decontamination for even the most challenging or complex devices.

We provide all the equipment and the expertise, saving you valuable time, money and inconvenience.

When the full cost of maintaining a bloodborne pathogen program, space, equipment (biohazard hoods), regulations, training, employees and management is considered: OUTSOURCING DECONTAMINATION IS THE LOWER COST OPTION