Request Information

C.G. Laboratories, Inc.

Reusable Medical Device Validation

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 FDA compliant device 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

Steam Sterilization

Sterrad Sterilization

Manual Cleaning

(protein & hemoglobin)

Automated Cleaning – protein & hemoglobin

(ISO 15883 compliant)

Disinfection Validation

(low, intermediate or high level)

Simulated Use Validation

(Functionality)

Thermal Disinfection Validation

Life Cycle

(continuous-cycle programming capabilities)

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 reusable medical device validation 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.

Key Benefits for Validation of Medical Devices

Ensures Patient Safety

Validation confirms that medical devices meet safety standards, reducing risks of harm or malfunction during use.

Proper validation ensures compliance with FDA, ISO, and other regulatory bodies, facilitating approval for market release.

Validation tests a device’s performance across multiple conditions, confirming its functionality and reliability over time.

By identifying potential issues early in the process, validation helps mitigate risks, minimizing the chance of device failures and recalls.

Through rigorous testing, validation helps establish consistent manufacturing processes, ensuring the device meets quality standards.

Validated devices reduce liability concerns by proving that the device is safe and effective for intended use.

Validated devices are more likely to gain market approval, boosting confidence among healthcare providers and patients.

Preventing device failures or regulatory non-compliance saves manufacturers money in the long run by avoiding costly recalls or lawsuits.
Laboratory Testing

Our FDA Compliant Device Validation Process

Initial Consultation

We collaborate with clients to understand their product goals and identify potential challenges before initiating the validation process.

Validation Planning

We develop a comprehensive validation plan tailored to the specific requirements of the reusable medical device, aligning with FDA guidelines.

Execution of Validation Studies

Our team conducts rigorous testing, including cleaning efficacy, sterilization, and functionality assessments, to ensure the device meets safety and performance standards.

Documentation and Reporting

We provide detailed reports documenting the validation process, results, and compliance with applicable standards, facilitating regulatory submissions.

Ongoing Support

We offer continuous guidance to address any issues that may arise post-validation, ensuring sustained compliance and device performance.

Who Conducts the Validation of Medical Devices?

At C.G. Laboratories, the validation is conducted by a team of experienced scientists, engineers, and regulatory experts. This multidisciplinary team collaborates to ensure that each device meets the necessary safety, efficacy, and regulatory standards. Their expertise spans various aspects of medical device validation, including sterilization, decontamination, and contract packaging services.

Types of Medical Device Cleaning Validation We Offer

At C.G. Laboratories, we offer comprehensive services to ensure the safety and efficacy of your reusable medical devices. It includes:

  • Manual Cleaning Validation
    Assessing the effectiveness of manual cleaning procedures in removing contaminants from devices.
  • Automated Cleaning Validation
    Evaluating automated cleaning systems to ensure they effectively clean devices according to established protocols.
  • Protein and Hemoglobin Testing
    Confirming that cleaning processes effectively remove biological residues, ensuring devices are safe for reuse.
  • Disinfection Validation
    Validating disinfection processes to ensure they effectively eliminate pathogens from devices.
  • Sterilization Validation
    Confirming that sterilization processes effectively eliminate all microbial life, ensuring device sterility.

These services are essential for ensuring that medical devices are properly cleaned and safe for patient use.

Frequently Asked Questions

What is the cost of reusable medical device validation?
It varies based on factors such as the complexity of the device, the number of tests required, and the validation processes involved (e.g., cleaning, sterilization, disinfection). For a detailed cost estimate, it’s best to contact C.G. Laboratories directly for a customized quote.
The turnaround time depends on the type of testing and the device involved. For a typical validation process, it can take several weeks to a few months. C.G. Laboratories works closely with clients to ensure timely completion while maintaining high standards of accuracy and thoroughness.
It benefits industries such as healthcare, medical device manufacturing, pharmaceuticals, and biotechnology. These industries rely on validated devices to ensure patient safety, regulatory compliance, and effective performance in healthcare settings.
Validation ensures that reusable medical devices remain safe, effective, and functional after each use. It guarantees proper cleaning, sterilization, and disinfection, which are critical to preventing infections and maintaining device performance across multiple cycles.
It is during the initial design and development phase, prior to the device’s first use. This ensures that the cleaning process is effective, and that the device can be safely reused without compromising patient safety.