Testing and approval of medical and medical devices

At the same time, the device must be approved for its intended use. FDA for Medical Devices; It has a testing and approval process that includes tests to determine the safety and functionality of the device.

Before devices can be made available to the public, they must be tested for adverse effects. As a Eurolab team, our laboratories are equipped with the latest technology for the approval of products worldwide; Medical device examinationStarts the most comprehensive testing and validation process for certification and global market access.

What is Medical Device Testing?

The process of evaluating and verifying the safety and effectiveness of a medical device before it is presented to patients. Medical device examination Is called. This includes testing the device in a laboratory setting as well as using it on patients in clinical trials.

Device; They are evaluated for specific performance and potential for loss. Device manufacturers; Before selling its products, it must comply with various legal requirements.

These requirements vary by device type, but include various tests to make sure the device meets certain performance standards and safety standards.

Medical and medical device tests

Medical equipment; To make sure they are safe and effective for use, they are tested differently. Some common tests include; Electrical safety test, mechanical safety test and performance test.

As Eurolab, we provide solutions to all testing and compliance challenges. The tests we perform are quite extensive and FDA approved.

  • Medical device safety check
  • IEC 60601-1
  • Medical device EMC test
  • FDA submission
  • Laser safety test
  • Battery testing and certification

At the same time, for testing and certification of medical devices;

  • Active Medical Device Product Safety Testing and Certification
  • Electromagnetic Compatibility of Active Medical Devices (EMC)
  • Laser safety testing in medical laser products subject to IEC 60601-2-22
  • Battery safety tests of all battery chemistry to strengthen medical equipment
  • RFID sensitivity of active medical devices

As Eurolab, for medical electrical products; With the certification of Certification Body NCB and Certification Body Test Laboratory CBTL, advanced technology medical devices in hospitals are also tested by our expert engineers.

What is the examination process in medical and medical instruments?

Testing process in medical and medical devices; It usually follows a step-by-step process designed to ensure the accuracy and reliability of its results.

  • First, the test samples are prepared and placed in the test equipment.
  • The equipment is set up according to the test specification.
  • The test is run and the results are recorded.
  • To determine if the test was successful, the data is analyzed.

To ensure that the device does not pose a fire risk, Electrical safety test And to ensure that the device does not harm patients or operators, Mechanical safety test Makes Performance testsEvaluates how well the device performs its intended function.

How does the approval process for medical and medical devices work?

Medical and medical devices go through multiple testing and approval processes before they become available. Approval process in medical and medical devicesA long and tedious process.

In order for a new device to be approved, it must go through multiple clinical trials to test its safety and effectiveness. Before the FDA can process and market a new device to consumers, there are several steps that must be taken.

The first step in the process is to submit an application to the FDA to the device manufacturer. The device manufacturer submits an application to the FDA to ensure that the application is complete and meets all regulatory requirements, and if approved, the FDA then conducts a thorough review to evaluate the safety and functionality of the device.

Here, as a Eurolab team, we complete the testing and approval process by examining, analyzing, measuring and evaluating medical devices and creating a complete report.

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