Sterilization and validation testing are essential to ensuring medical device safety, regulatory compliance, and successful commercialization. Life Science Outsourcing (LSO) provides end-to-end validation testing services to support medical device manufacturers from development through commercial production.
As an FDA-registered, ISO 13485–certified contract manufacturer, LSO supports compliance with ISO 11135, ISO 17665, ISO 11737, ISO 10993, and USP standards. Our integrated testing capabilities reduce risk, simplify validation, and accelerate timelines.
Bacterial endotoxin testing (BET), or LAL testing, ensures that medical devices and materials meet pyrogen-free requirements to prevent harmful inflammatory responses in patients. LSO provides:
Bioburden testing measures the microbial contamination levels on a medical device before sterilization. Our services include:
Cytotoxicity testing evaluates the potential toxic effects of a medical device on living cells, ensuring biocompatibility and patient safety. LSO offers:
Regulatory-compliant labeling is critical for traceability, UDI compliance, and patient safety. LSO offers:
Microbial identification is essential for understanding contaminant sources and mitigating risks in medical device manufacturing. Our testing includes:
Sterility testing confirms that medical devices are free from viable microorganisms after sterilization. Our services include:
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