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Medical Device Testing

We offer medical device, medical product, and medical packaging testing.

With the analytical expertise and product testing experience needed to ensure safe and effective performance of a range of medical products and medical devices we can provide validated test methods for 510K submission and for pre-market approval.

We work with compendial methods and will also develop and validate custom testing methods for your specific needs.  SGS Polymer Solutions offers cGMP testing services on large or small projects.  We are also FDA Registered, cGMP Compliant, and DEA Licensed.  These quality credentials testify to our commitment to the most stringent scientific rigor. 

Our comprehensive testing methods ensure safe and effective performance of a wide variety of medical devices and medical products.  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:

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

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
  • Residual solvents analysis
  • Residual catalysts analysis
  • Shelf-life stability tests

Physical Tests:

  • Flexural testing
  • Film layer analysis
  • Failure analysis
  • Embrittlement testing
  • Compression testing
  • Packaging analysis
  • Release testing
  • Stress testing
  • Tensile testing

Medical Products Testing:

  • Biomaterials analysis
  • Implants
  • Medical device testing
  • Disposable medical products
  • Sterilization bags
  • Bottles
  • Stents
  • Maxillofacial reconstruction devices
  • Regenerative medicine devices
  • Tissue engineering
  • Drug delivery systems
  • Tissue scaffolds
  • Combination device testing

Aging Chemical Resistance Testing

Bioabsorbable Polymer Testing

Extractables Leachables Testing

Implant Analysis

Microstructural Analysis

Molecular Weight Analysis

Poloxamer Testing

Quality Assurance

Residual Monomer Analysis

Residual Solvent Analysis

Transparent Liquid Color Measurement