Medical Device, Product, and Packaging Testing Services

Medical Device Services

SGS PSI medical device testing services include:

• Failure analysis
• Lot release testing
• Packaging analysis
• Pre-market testing
• Test method validation
• Test method development
• Certification
• Risk assessment
• FDA submission
• Stability and shelf-life

Our comprehensive testing methods ensure safe and effective performance of a wide variety of medical devices and medical products. We are FDA registered, cGMP compliant and DEA licensed. As an independent lab we also provide validated testing for 510K submission for pre-market approval. 

A combination of chemical analysis and physical testing methods are used to study medical devices, products, and packaging for humans and veterinary applications, including for example:

CHEMICAL TESTS

• Residual monomers analysis
• Residual moisture analysis
• Level of crystallinity determination
• Molecular weight analysis
• RoHS testing
• Compositional analysis
• Contamination analysis
• Extractables and leachables testing
• In vitro testing

PHYSICAL TESTS

• Flexural testing
• Film layer analysis
• Failure analysis
• Embrittlement testing
• Compression testing
• Packaging analysis
• Release testing
• Residual solvents analysis
• Residual catalysts analysis
• Shelf-life stability tests
• Stress testing
• Tensile testing

End-to-End Testing for Medical Devices

Our scientists perform chemical analysis and physical testing of medical devices, products, and packaging at each stage of the product life cycle. We call this end-to-end testing. We assist clients from concept to packaging assessment as the product evolves from the design, to trial, to manufacturing: material selection for novel medical products, prototypes, submission, production, sterilization, and shelf-life assessment. We have helped clients in these diverse medical device areas:

• Bioabsorbable scaffolds
• Biomaterials
• Bone scaffolds
• Bottles
• Disposable medical products
• Drug delivery systems
• Implants
• Maxillofacial reconstruction implants
• Regenerative medicine products
• Stents
• Sterilization bags
• Tissue engineering materials
• Tissue scaffolds

We have extensive experience with the materials used in medical devices, products, and packaging.  The materials we test include plastic, rubber, metals, ceramics, adhesives, and coatings.  

We have highly specialized expertise with the families of biocompatible, biodegradable, and bioabsorbable polymers, such as the polylactide, polyglycolide, polycaprolactam materials, copolymers, and blends.  We also routinely evaluate other polymers, engineering resins (such as polyurethanes, polyesters, polyamides, polyimides), ultra-high molecular weight polyethylene, ceramics, and metals used for medical device implants, other medical products, or medical packaging.

Performance Testing for Medical Devices

Over the years, we have tested various polymer material types to evaluate their long-term performance. Careful and accurate material selection protects against product failure. A partial list of the medical devices, medical products, and medical packaging we've tested includes:

• Biosorbable screws
• Breast implants
• Contact lenses
• Drug eluting stents
• Implants
• IV fluids bags
• Metered dose inhalers
• Orthopedic tools
• Resorbable mesh
• Scalpels
• Sutures
• Syringes

Contact us to discuss your specific medical device, medical product, or medical packaging testing project.