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List of Harmonized Standards

Medical Device Testing

Medical Device Testing is inevitable and must be performed to ensure the quality, safety, and performance are met and safe for human use. Ther are multiple tests to demonstrate compliance with regulations or standards.

Medical Device Testing Service

Medical Device Testing Service

Depending upon the nature of the Medical Device and its constructional materials, the test requirements will change. It might change based on country-wise regulations too.

The test protocols should be prepared in compliance with the specific standard(s) and corresponding test reports with results should be generated.

  1. Material Characterization
  2. Analytical Tests
  3. Preclinical Tests
  4. Biocompatibility Tests
  5. Sterility Assurance
  6. Microbiology tests
  7. Metallurgical tests

Medical Device Testing Laboratories

There are many laboratories worldwide offering medical device testing services. It is very important to understand all laboratories is good and can produce acceptable protocols and reports EU Notified Bodies or US FDA is looking for.  Laboratories must have the necessary infrastructure and accreditation to carryout medical device tests.

  • International Accreditations.
  • Technical Expertise.
  • Animal test house / Laboratory.