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Medical Device


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With the combination of experienced analytical scientists and a rigorous quality program, Impact Analytical has become a major supplier of analytical service to the medical device industry. Our scientists have expertise analyzing a wide range of sample types; including plastics, raw materials, chemicals, contaminants, and gases. Impact’s quality program includes a full-time quality manager, a 4-person audit team, and an experienced QAU (quality assurance unit). Impact is ISO 9001:2000 certified, and GLP/cGmP compliant. Services offered to the Medical Device industry include:
  • Material Identification
  • Product Deformulation
  • Contaminant Identification
  • Production Problem Solving
  • Regulatory Testing
  • Methods Development and Validation
  • Raw Materials Analysis
  • Thermal/Mechanical Properties Measurement
  • Gas Analysis
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