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MEDICAL DEVICE TESTING

SGS Life Science Services in North America offers high quality testing services to medical device companies.  From product development to finished product quality control, our services are targeted to meet the medical device manufacturer’s testing requirements.  Services include analytical chemistry, microbiology and sterility assurance testing.  Test procedures are based on AAMI, ISO, FDA, USP, client SOPs and other methods and guidelines.

Index of Medical Device Testing Services

Accelerated Aging of Medical Devices

          Microbial Environmental Monitoring Supplies                     

Antimicrobial Preservative Effectiveness Test

  Microbial Limits – USP
Bacteria Identification

  Microbial Samples – Incubation, Enumeration
Bacteriostasis/Fungistasis

  Microbiological Analyses
Bioburden Analyses

  Package Integrity Tests
Bioburden Method Validation – Recovery Study

  Packaging Tests
Biological Indicators

  Particulate Matter – Medical Devices
Dose Audits AAMI/ISO

  Particulate Matter
Environmental Survey

  Physical Tests
Ethylene Oxide Residues Tests

  Physicochemical Tests – USP
Extractables Testing

  Post-Sterilization Tests
Gas Chromatography

  Product Inoculation
Infrared Spectroscopy

  Purified Water Monograph – USP
LAL Bacterial Endotoxins Tests

  Reusable Medical Device Testing
LAL Validation

  Sample Item Portion (SIP) Preparation
Liquid Chromatography

  Spore Strip Population Verification
Materials Qualification

  Sterility Audits

Metals – Quantitation By Atomic Absorption

  Sterilization Validations – Microbiological

Microbial Environmental Monitoring
  UV/Visible Spectroscopy

Water – Microbiological Analyses
  Water – Microbiological Analyses

Water System Validation Projects
 
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