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Medical Device Testing

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Medical Device Testing

As we rely on the proficiency of the medical device to perform as intended, the slightest deficiency in the medical device can provide tragic results.

Medical device testing evaluates various aspects of the medical devices to block the usage of the defective devices on patients. Medical device testing also demonstrates that the medical device is safe and reliable to use. In short Medical device, testing indicates Medical device is certified to perform as per intended use. Medical device testing facilitates you to provide evidence of its compliance with standards and regulations around the globe.

Medical device testing includes:

  • Performance testing
  • Bio-compatibility testing’s
  • Clinical and pre-clinical testing’s
  • Chemical Analysis
  • Quality Assurance testing (Dimensional check and functional testing’s)
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Medical Device Testing Services

  • The test requirements for each type of medical device are different. These testing requirements are in turn based on the material, manufacturing process of medical devices, applicable standards, and regulations.
  • We advise you on what testing are to be carried out on your Medical device. We assist you to co-ordinate with the accredited lab to execute the testing.

Medical Device Testing Laboratories

There are numerous labs available that provide testing for a wide range of the medical devices. The labs are selected based on the certifications it has. The testing protocol and report content used by the lab shall be approved by notifying bodies. The labs shall be ISO 17025 accredited. Various tests require the labs to be GLP certified.

Medical Device expertise

We guide you on selecting the appropriate labs based on the requirements of your Medical device testing.

We interpret the test standards and guidelines to determine the test requirements and adequate test methods to be used for your device. We help you determine test parameters and acceptance criteria.

FAQ:

The general standard that is not specific to the medical device includes packaging ISO 11607, toxicity ISO 10993, IEC 62366.

It is a regulatory requirement ensuring that the device is compatible with the biological system where it will use.

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