C.G. Laboratories, Inc. specializes in the validation and development of Manufacturer’s Instructions for Use (IFU) for Reusable Medical Devices. As per FDA regulations, the responsibility for testing and validating any labeling claims for reuse provided in the IFU rests with the device manufacturer. This includes overseeing the handling, cleaning, disinfection, and sterilization processes of reusable medical devices in a healthcare facility. C.G. Laboratories provides guidance to clients throughout the validation process, ensuring that their product goals are met and identifying any potential issues before validation begins. This proactive approach maximizes the likelihood of success by addressing any challenges early in the process, ultimately leading to improved outcomes and greater confidence in the safety and efficacy of the validated reusable medical devices.
Applicable Standards: AAMI TIR 12 and AAMI TIR 30
FDA guidance document: Reprocessing Medical Devices In Health Care Settings: Validation Methods and Labeling
Aspects Validated for Reusable Devices
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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.
