Demonstrating rigorous scientific integrity, ISO 13485:2016 compliance, MDSAP audit readiness, and FDA registrations for international medical device procurement.
At C.G. Laboratories, Inc., our robust Quality Management System (QMS) forms the foundation of every testing protocol, sterilization validation, and contract packaging procedure we perform. Certified by leading registrar Intertek and registered with global regulatory authorities, our credentials empower medical device OEMs, tissue banks, and healthcare suppliers to cross regulatory hurdles seamlessly worldwide.
Full establishment registration with the U.S. Food and Drug Administration (FDA) for tissue processing support and medical device microbiological testing. Ensures full alignment with 21 CFR Part 820 and 21 CFR Part 1271 regulatory standards.
Accredited under the Clinical Laboratory Improvement Amendments (CLIA), authorizing high-complexity analytical testing. Assures precision, reproducibility, and rigorous standard operating procedures across all microbiological determinations.
Comprehensive Quality Management System certification audited by Intertek. MDSAP (Medical Device Single Audit Program) approval validates our compliance across five major global jurisdictions: USA, Canada, Australia, Japan, and Brazil.
Procurement officers and quality directors for international medical equipment manufacturers require total transparency and undeniable data integrity. C.G. Laboratories maintains an open-door policy for vendor quality audits, supporting overseas client technical reviews with thorough documentation.
One single audit covers requirements for US FDA, Health Canada, TGA (Australia), MHLW/PMDA (Japan), and ANVISA (Brazil), streamlining your global supply chain approval.
Every test parameter, standard operating procedure (SOP), and validation execution is documented according to strict Good Laboratory Practices (GLP) and ISO 17025 / 13485 requirements.
Over four decades without critical audit findings, backed by 90+ years of cumulative scientific leadership across our laboratory engineering staff.
| Certification Standard | Issuing Body / Authority | Global Scope |
|---|---|---|
| ISO 13485:2016 | Intertek Testing Services | Worldwide Standard |
| MDSAP Accreditation | IMDRF Auditing Organizations | US, CA, AU, JP, BR |
| FDA Registration | U.S. FDA (Department of HHS) | United States & Imports |
| CLIA Compliance | CMS / Federal Regulations | Clinical Lab Testing |
| AAMI / ISO Standard Compliance | AAMI / ISO / ANSI | Sterilization Validation |
Our quality assurance team provides international clients with official certificate packages, auditor packets, and complete validation protocol support to accelerate your product approval.
