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. Our Laboratory Department, which is certified by ISO 13485:2016, is a well-equipped facility with a team that collectively has over 90 years of experience in serving the medical device industry. At C.G. Laboratories, Inc., we are dedicated to upholding sound scientific principles.

Comprehensive Laboratory Testing Services
C.G. Laboratories offers a wide range of laboratory testing solutions that help ensure the safety and performance of medical devices in real-world clinical environments.

Certified Laboratory for Medical Device Testing
Our laboratory is ISO 13485:2016 certified, ensuring quality management practices that align with global regulatory standards. Our medical device testing laboratory is equipped to perform testing in accordance with FDA guidance and ISO standards.

Reusable Medical Device Validation
We specialize in the validation of medical devices intended for reuse. This includes detailed testing protocols to verify the cleaning, disinfection, and sterilization instructions provided by the manufacturer. Each validation is meticulously designed to simulate clinical use and reprocessing cycles.

FDA-Compliant Device Validation
Our FDA-compliant device validation services support manufacturers in meeting U.S. regulatory requirements. Whether you're launching a new product or updating an IFU, we provide reliable, evidence-based testing for cleaning, packaging, and labeling claims.

Validation for Reusable Medical Devices
Medical device reuse requires robust testing to ensure continued safety and effectiveness. We conduct comprehensive validation for reusable medical devices, including soil challenge studies, extraction analysis, and residual testing post-cleaning.

Medical Device Cleaning Validation
Our medical device cleaning validation services help confirm that cleaning instructions effectively remove contaminants and soils. We use worst-case device configurations and clinically relevant soils to ensure accurate and reliable results.

Medical Device Validation Services
From sterilization and packaging to biocompatibility and usability testing, our medical device validation services are designed to support each phase of your product development and approval lifecycle.

Medical Device Decontamination Services
As a specialized medical device decontamination lab, C.G. Laboratories delivers highly controlled, compliant solutions for decontaminating reusable instruments before cleaning validation.

ISO 13485 Certified Decontamination Service
Our decontamination processes are validated under strict quality protocols and fully aligned with ISO 13485 standards, ensuring consistent, reproducible, and audit-ready documentation.

MDSAP Certified Decontamination Service
We’re proud to be a MDSAP certified decontamination service provider, capable of supporting medical device manufacturers across multiple regulatory jurisdictions, including the U.S., Canada, Japan, Brazil, and Australia.

Medical Device Decontamination Provider
As a dedicated medical device decontamination provider, we offer customized protocols for complex instruments and lumened devices. Our goal is to replicate actual clinical conditions to test cleaning claims effectively.

Medical Device Decontamination Solutions
We design and implement medical device decontamination solutions tailored to the specific materials, configurations, and intended use of each device. From manual cleaning to automated washer-disinfector compatibility, we deliver comprehensive evaluations.

Why Choose C.G. Laboratories?
Choosing the right laboratory testing provider is crucial to bringing a safe and compliant medical device to market. Here’s why top manufacturers trust C.G. Laboratories:

Regulatory Expertise You Can Trust
With decades of experience and in-depth knowledge of FDA and ISO requirements, we offer professional laboratory testing services that help reduce risk and accelerate market approval.

State-of-the-Art Facility
Our accredited testing lab is equipped with advanced instrumentation to conduct high-precision testing and decontamination procedures under controlled environmental conditions.

End-to-End Support for IFU Validation
We partner with manufacturers at every stage—from designing protocols and executing tests to compiling validation reports that are submission-ready for regulatory authorities.

Science-Driven Methodology
At C.G. Laboratories, we maintain a commitment to sound scientific principles in every test we perform. Our methods are designed for accuracy, reproducibility, and traceability.

Collaborative Approach
We work closely with our clients to understand the nuances of their devices, tailoring every test protocol to address unique challenges in cleaning, decontamination, and sterilization.

Our Core Testing & Validation Capabilities
Cleaning validation for reusable surgical instruments

Disinfection and sterilization validation

IFU development and validation

Material compatibility assessments

Simulated use and worst-case scenario testing

Protein, hemoglobin, and carbohydrate residual analysis

Extraction studies and chemical characterization

Packaging and label claim testing

Environmental monitoring and contamination control

Serving the Global Medical Device Industry
C.G. Laboratories is more than just a testing lab—we are a strategic partner in product development, regulatory compliance, and patient safety. As an ISO 13485 certified laboratory and FDA-registered facility, we serve device manufacturers from across the globe, ensuring that their products meet or exceed international safety and performance standards.

Ready to validate your reusable medical device or IFU?
Choose C.G. Laboratories for reliable, accurate, and regulatory-compliant medical device testing and decontamination services. Visit https://cg-labs.com to learn more or contact our team to start your project today.
 
Business Phone: +1 817-279-1945

Hours of Operation: Monday - Friday : 8:00am – 5:00pm