Comprehensive biological evaluation, extractables & leachables (E&L), sterility validation, and physical performance testing for Class I, II, and III medical devices.
FTIR, DSC, TGA, and XRD spectroscopic identification of medical grade polymers and metals.
Comprehensive GC-MS, LC-MS, and ICP-MS profiling of chemical leachables per ISO 10993-18.
Quantitation of residual monomers, additives, plasticizers, and processing aids.
Ethylene Oxide (EtO) and Ethylene Chlorohydrin (ECH) residual determination per ISO 10993-7.
In-vitro MEM elution and MTT assays (ISO 10993-5) evaluating cell viability impact.
Guinea pig maximization test (GPMT) and closed-patch assays (ISO 10993-10).
Intracutaneous reactivity and primary skin irritation assessment (ISO 10993-23).
Hemolysis, complement activation, and thrombosis evaluation for blood-contacting devices (ISO 10993-4).
Material-mediated pyrogenicity and bacterial endotoxin (LAL) testing (ISO 10993-11).
Subcutaneous and intramuscular tissue response evaluation post-implantation (ISO 10993-6).
Acute, sub-acute, and sub-chronic systemic toxicity screening per ISO 10993-11 standards.
Sterility validation of finished medical devices per USP <71> and ISO 11737-2.
Pre-sterilization bioburden recovery and microbial count determination (ISO 11737-1).
LAL kinetic endotoxin quantitation for implants and sterile fluid pathway devices.
Microbial barrier testing, dye penetration, and bubble emission leak testing (ASTM F1929).
Tensile, elongation, and yield strength testing of catheters, tubing, and sutures.
Cyclic fatigue and compressive load testing of orthopedic implants and stents.
Peel strength testing (ASTM F88), burst testing, and sterile barrier packaging validation.
