Explore our full range of critical validation testing services—trusted methods to ensure your medical devices meet the highest safety and compliance standards.
At Life Science Outsourcing, we understand that validation isn’t just a requirement—it’s a commitment to safety, performance, and patient outcomes. Our comprehensive validation testing services are designed to help medical device manufacturers navigate complex regulatory pathways with confidence. From Bioburden to Sterility and Cytotoxicity testing, our proven methods and industry expertise ensure your products meet global standards while accelerating your time to market.
Bioburden testing is one method of many used in medical device sterilization testing processes. Learn more about this important method, who needs it, and how it works.
Cytotoxicity testing is used to verify that a device or material is safe for intended use in contact with the human body.
EO residual testing ensures the safety and compliance of medical devices sterilized by ethylene oxide.
Microbial identification tests identify and characterize microorganisms before or after sterilization.
Product sterility testing is part of the sterilization validation process to show that devices would be free of viable microorganisms after the sterilization process is complete. Unlike biological indicator sterility testing, product sterility testing is performed on the device itself.
As an FDA-registered and ISO 13485-certified contract manufacturing organization, Life Science Outsourcing (LSO) offers assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design. Our unique business model combines comprehensive in-house services and extensive regulatory expertise, allowing us to provide the agility and flexibility needed to expedite market launches while standardizing the supply chain and minimizing risks.
Comprehensive packages for regulatory compliance.
From fractional to full cycles with EtO residual testing.
Secure with 2X qualification.
Tailored to your sterilization needs.
Life Science Outsourcing is an FDA registered and ISO 13485 certified full service Medical Device Contract Manufacturer.
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