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C.G. Laboratories, Inc.

Medical Device Decontamination Service

  • MDSAP & ISO 13485 Certified

  • Comprehensive Decontamination Solutions

  • Expertise in Medical Device Processing

  • FDA-Registered

  • Advanced Tracking & Monitoring

Seamless Medical Device Decontamination Process

At C.G. Laboratories, Inc., we make the medical device decontamination process simple, efficient, and fully compliant with regulatory standards.

Step 1: Device Intake & Inspection

Devices arrive at our ISO 13485-certified facility, undergo initial inspection, and are logged into our tracking system for full oversight.

Step 2: Pre-Decontamination Cleaning

Manual cleaning removes visible debris, and devices are disassembled if necessary to ensure full exposure to sterilization agents.

Step 3: Selection of Decontamination Method

Based on material type, contamination level, and regulations, we select ethylene oxide, steam, liquid, gamma radiation, or custom sterilization.

Step 4: Decontamination & Sterilization

Devices undergo validated sterilization in a controlled environment, ensuring complete elimination of biological contaminants, bacteria, and viruses.

Step 5: Compliance Testing & Quality Control

Post-decontamination, devices are tested for sterility, inspected for integrity, and validated to meet ISO 13485, FDA, and MDSAP standards.

Step 6: Packaging & Secure Shipment

Sterilized devices are securely packaged, documented, and tracked in real-time for safe delivery to clients, ensuring regulatory compliance.

MDSAP Certified Decontamination Service

At C.G. Laboratories, Inc., we specialize in providing medical device decontamination services that meet the highest industry standards.

Our MDSAP-certified decontamination service and ISO 13485-certified decontamination service guarantee effective decontamination, ensuring that medical devices are free from harmful contaminants before they are inspected, tested, or reused.

As a trusted medical device decontamination provider, we help healthcare facilities, medical manufacturers, and research institutions maintain compliance and patient safety. Whether you need a standard or a custom medical device decontamination solution, our team of experts is here to help.

Available Decontamination Methods

We provide multiple decontamination methods to ensure thorough sterilization of medical devices. Our ISO 13485 certified decontamination service include:

Ethylene Oxide (EtO) Sterilization

Ideal for medical devices that are heat- or moisture-sensitive. This method ensures deep penetration and eliminates contaminants without damaging delicate instruments.

A chemical-based method that effectively sterilizes surgical instruments, implants, and reusable medical tools.

Uses high-temperature steam and chemical sterilants (like Cidex OPA) for effective microbial elimination. It is best suited for stainless steel and robust device materials.

Suitable for single-use and polymer-based devices. It provides fast, effective microbial elimination without thermal exposure.

We develop and validate specialized medical device decontamination solutions based on the needs of each client.

Laboratory Testing

Ready to Ensure Safe & Compliant Medical Device Decontamination?

Industry Experts

Over 40 years of excellence in medical device decontamination.

Hassle-Free Submission

Easy-to-use online intake form for quick processing.

Accredited & Compliant

Certified by ISO and CLIA for quality and safety

State-of-the-Art

Facility equipped with the latest sterilization technology.

Laboratory Testing Services Offered

The laboratory offers a wide array of testing services, such as:

  • Aging Study/Stability Study Services

  • Aqueous Biocide

  • Bioburden Testing Services

  • Endotoxin Testing

  • Biological Indicator Services
  • Nutritional/Dietary Testing Services
  • Identification Services
  • Validation Services
  • Packaging Integrity Services
  • Product Sterility Services
  • Product Testing Services
  • Water Testing Services
  • Miscellaneous Testing

  • Miscellaneous Testing

  • Environmental Services

  • Dialysis Water Testing

contract packaging

Advantages of Medical Device Decontamination Services

  • Ensures Patient & Staff Safety
    Removes harmful bacteria, viruses, and contaminants, reducing infection risks in medical environments.
  • Regulatory Compliance
    Meets FDA, ISO 13485, CDC, and OSHA standards, ensuring safe and compliant device reprocessing.
  • Extends Device Lifespan
    Proper sterilization prevents damage, allowing reusable medical instruments to function safely for longer.
  • Custom Sterilization Options
    Offers multiple methods, such as ethylene oxide, steam, and gamma radiation, to suit various device materials.

Industries We Serve

Our medical device decontamination services cater to a wide range of industries that require safe, compliant, and effective sterilization solutions.

  • Hospitals & Healthcare Facilities
    Ensuring surgical instruments and medical devices are free from contaminants before re-use or disposal.
  • Medical Device Manufacturers
    Supporting pre-market testing and post-market surveillance with validated decontamination processes.
  • Research Laboratories
    Providing sterilization for lab equipment, biological samples, and medical testing devices.
  • Forensic & Investigative Services
    Safely decontaminating medical instruments used in forensic and legal investigations.
  • Veterinary & Dental Practices
    Offering specialized sterilization for reusable instruments in non-hospital medical environments.

Frequently Asked Questions

Why is ISO 13485 certification important for decontamination?

ISO 13485 certification ensures that decontamination processes meet international quality management standards, guaranteeing safety, effectiveness, and compliance.

MDSAP (Medical Device Single Audit Program) certification allows global regulatory authorities to recognize CG Laboratories’ decontamination processes as safe and compliant.

Our medical device decontamination lab offers ethylene oxide sterilization, steam and liquid decontamination, gamma radiation sterilization, and custom sterilization solutions.

We, as your reliable medical device decontamination provider, offer a validated tracking software system that monitors each shipment in real-time, ensuring transparency and compliance.

Yes, we conduct in-house validations to confirm the effectiveness and compatibility of our decontamination methods with various medical devices.

Our ISO 13485 and MDSAP-certified processes comply with FDA, CDC, OSHA, and DoT regulations, ensuring full regulatory adherence.

Yes, we provide custom decontamination and sterilization methods based on device complexity and manufacturer requirements.

Turnaround time depends on device type and method used, but our real-time tracking system ensures timely updates.