Medical Device Testing & Validation Services

ISO 13485:2016 & MDSAP Accredited Laboratory Solutions — Upholding Rigorous Scientific Standards for Medical Device Manufacturers Worldwide

ISO 13485:2016

Certified Quality Management System for Medical Devices

MDSAP Accredited

Medical Device Single Audit Program International Compliance

FDA Registered

Full Regulatory Compliance for US & Global Submissions

40+ Years Expertise

Proven Scientific Integrity & Technical Precision Since 1983

ISO 13485 Certified Microbiology Laboratory Testing for Medical Devices
Department 01

Microbiology & Laboratory Testing Services

Our ISO 13485:2016 certified laboratory brings over 90 years of combined team experience in microbiological testing for medical device manufacturers. We perform rigorous analytical testing essential for regulatory clearance, batch release, and safety assurance according to USP, AAMI, and ISO standards.

Bioburden Determination
Product Sterility Testing
Bacteriostasis & Fungistasis (B/F)
Chromogenic Endotoxin (LAL)
AAMI Quarterly Dose Audits
Dialysis Water & Fluid Testing
Reusable Medical Device Reprocessing and IFU Validation Testing
Department 02

Reusable Medical Device Reprocessing & IFU Validation

Per FDA regulatory mandates, medical device manufacturers are required to validate all cleaning, disinfection, and sterilization instructions provided in the Instructions for Use (IFU). C.G. Laboratories specializes in custom protocol development, residual soil testing, and full cycle validation to support compliant device reuse.

Automated & Manual Cleaning Studies
Protein, Hemoglobin & TOC Residual Analysis
High-Level Disinfection Validation
FDA 510(k) Reprocessing Protocol Support
Washer Disinfector Validated to ISO 15883 Standards
Department 03

Washer Disinfector Validation (ISO 15883 Compliant)

We offer advanced washer disinfector capabilities engineered and validated to ISO 15883 standards. Our equipment features fully customizable thermal and chemical disinfection cycles tailored to meet specific medical device geometry and cleaning parameters for complex surgical tools.

ISO 15883 Compliance Testing
Thermal Disinfection Ao Value Calculation
Custom Cleaning Cycle Optimization
Detergent Compatibility Evaluation
Turnkey Medical Device Decontamination and Sterilization Services
Department 04

Medical Device Decontamination Services

C.G. Laboratories provides specialized decontamination services for explanted, complaint, or returned medical devices used in surgical and clinical procedures. Operating under strict biohazard controls, our team delivers rapid processing with a consistent operational objective of 72-hour turnaround time.

72-Hour Decontamination TAT Objective
Complaint & Explant Device Processing
Customized Bio-Decontamination Protocols
Complete Decontamination Documentation
Sterile Medical Device Contract Packaging and Sealing Validation
Department 05

Contract Packaging & Integrity Validation

We provide turn-key contract packaging solutions for sterile medical devices and non-sterile healthcare products in ISO-controlled environments. From pouch and tray pouch sealing to complete shelf-life stability studies, we ensure your product's barrier system remains fully compromised-free from manufacture to patient care.

Pouch & Rigid Tray Heat Sealing
ISO 11607 Sealing Validation
Bubble Emission & Dye Penetration Integrity
Accelerated & Real-Time Aging Studies
Hydrogel Contract Manufacturing and OEM Formulation Services
Department 06

Hydrogel Contract Manufacturing & Formulation

With over 13 years of specialized experience in hydrogel production, C.G. Laboratories delivers complete OEM formulation, batch mixing, and specialty packaging solutions. Our custom hydrogel formulations cater to wound care, medical diagnostics, cosmetic applications, and therapeutic delivery systems.

Custom Formulation & Viscosity Tuning
Bulk Compounding & Precision Dispensing
Wound Care & Diagnostic Pad Packaging
Sterility & Biocompatibility Support
Industrial Sterilization Validation for Ethylene Oxide, Steam, and E-Beam
Department 07

Industrial Sterilization Validation (EtO, Steam, E-Beam)

C.G. Laboratories is an industry-recognized leader in design, execution, and protocol generation for terminal sterilization processes. We guide clients through regulatory requirements to ensure Sterility Assurance Levels (SAL 10⁻⁶) under ISO 11135 (Ethylene Oxide), ISO 17665 (Steam), and ISO 11137 (Radiation).

Ethylene Oxide (EtO) Cycle Validation
Moist Heat (Steam Autoclave) Qualification
Electron Beam (E-Beam) & Gamma Validation
Biological Indicator (BI) Inoculation & Testing
E-Beam Radiation Sterilization Dose Determination and Audit Services
Department 08

E-Beam & Radiation Sterilization Validation

Our radiation sterilization team provides expert guidance for Electron Beam (E-Beam) sterilization dose setting, bioburden audits, and material compatibility testing under ISO 11137 standards. We assist medical device manufacturers in establishing precise minimum and maximum dose limits for optimal sterility assurance.

Method 1 & VDmax Dose Audits
Sub-lethal Dose Verification Testing
Maximum Dose Material Tolerance Testing
AAMI ISO 11137 Regulatory Protocol Support
Environmental Monitoring Program and Cleanroom Particle Counting
Department 09

Environmental Monitoring & Cleanroom Services

Proactive environmental control is critical to medical device quality and cGMP compliance. We establish, execute, and audit routine environmental monitoring programs for cleanrooms and controlled assembly spaces under ISO 14644 standards, providing routine sampling, isolate identification, and equipment rentals.

Active Air Microbial Sampling
Surface & Personnel Contact Testing
Cleanroom Disinfection Validation
Calibrated Particle Counter Rentals
Medical Device Regulatory Compliance and Quality Assurance Consulting
Department 10

Regulatory Compliance & Quality Consulting

In addition to analytical testing, C.G. Laboratories acts as a strategic regulatory partner for medical device developers globally. Our senior scientists and quality auditors provide hands-on consulting for FDA 510(k) submissions, technical file development, process validation (IQ/OQ/PQ), and QMS audit preparation.

FDA 510(k) & CE Mark Testing Strategy
Equipment & Facility Qualification (IQ/OQ/PQ)
Standard Operating Procedure (SOP) Development
ISO 13485 & MDSAP Audit Readiness
Tissue Testing Laboratory Services for Tissue Banks and Biologics
Department 11

Tissue Testing Laboratory Services

C.G. Laboratories delivers quality-driven microbiological testing tailored specifically to human tissue banks, biologics manufacturers, and regenerative medicine firms. Our specialized protocols protect tissue graft integrity while meeting stringent safety benchmarks for clinical application.

Tissue Allograft Bioburden & Sterility
Aqueous Biocide Efficacy Testing
Bacterial & Fungal Isolate Identification
AATB & FDA Tissue Regulations Support

Ready to Discuss Your Testing & Validation Requirements?

Speak directly with our technical laboratory experts to receive customized protocol estimates, regulatory advice, or project turnaround schedules tailored to your medical device portfolio.

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