Medical Device Testing
Ensure your medical devices meet global safety and compliance standards with LSO’s expert sterilization validation testing services.
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.
- 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.
- 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.
- 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.
- 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)
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:
How Does Medical Device Validation Testing Work?
Medical Device Validation Testing within SVS generally includes:
Validation Testing Services Available Through SVS
SVS provides Medical Device Validation Testing services that include:
What Standards Apply?
Medical Device Validation Testing within SVS is performed in accordance with applicable regulatory and standards-based requirements, including:
About SVS
FDA-Registered
Manufacturing Facility
ISO 13485
Certified Quality System
12 Cleanrooms
Class 5–8
125,000+ Sq Ft
Regulated Manufacturing
3 Facilities
CA | NH | Costa Rica
Ready to get started?
Talk to a specialist about medical device testing.