Medical Device Testing

Validation testing is a core function of Life Science Outsourcing’s Sterilization Validation Services (SVS) division. These services support the verification of sterility, biological safety, and process effectiveness required for regulated medical device manufacturing.

LSO provides validation testing to support product development, sterilization validation, and commercial release activities. All testing is performed within FDA-registered, ISO 13485-certified facilities and aligned with applicable international standards and regulatory expectations.

What Is Validation Testing for Medical Devices?

Medical Device Validation Testing is defined as laboratory testing performed to generate objective evidence that a medical device, material, or sterilization process meets predefined regulatory, safety, and performance requirements. Within SVS, Medical Device Validation Testing supports the verification of sterility, biological compatibility, and process effectiveness required for regulated medical device manufacturing.

Who Needs Medical Device Validation Testing?

Medical Device Validation Testing is required or commonly performed by:

Medical device startups preparing products for initial regulatory submission or clinical use
Medical device OEMs scaling from development into commercial manufacturing
OEMs performing sterilization process validation or revalidation
Contract manufacturers supporting regulated production activities
Quality and regulatory teams preparing documentation for regulatory submissions or audits

Testing requirements vary based on device classification, intended use, and applicable regulatory standards.

How Does Medical Device Validation Testing Work?

Medical Device Validation Testing within SVS generally includes:

Definition of testing scope based on regulatory and validation requirements
Selection of representative device samples and configurations
Execution of testing using defined, standards-based laboratory methods
Evaluation of results against established acceptance criteria
Generation of formal test documentation to support validation and compliance activities

Testing activities are coordinated to align with sterilization validation protocols and regulatory documentation.

Validation Testing Services Available Through SVS

SVS provides Medical Device Validation Testing services that include:

Bacterial endotoxin testing
Bioburden testing
Cytotoxicity testing
EO residual testing
Microbial identification
Sterility testing

Each testing service is governed by defined standards and performed under controlled laboratory conditions.

What Standards Apply?

Medical Device Validation Testing within SVS is performed in accordance with applicable regulatory and standards-based requirements, including:

ISO 11135 — Ethylene oxide sterilization
ISO 17665 — Moist heat sterilization
ISO 11737 — Bioburden and sterility testing
ISO 10993 — Biological evaluation of medical devices
USP <85> — Bacterial endotoxins
FDA Quality System Regulation (21 CFR Part 820)