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Steps to Medical Product Test Completion

Know how to complete your medical device tests after reports are received.

Photo of doctors analyzing data

October 5, 2020

What to do after receiving your test report

You have just successfully completed your product evaluation to a wide range of standards.  With the completion of those evaluations comes a large number of reports that document the product under evaluation, what standards were used and test data gathered.  It may be tempting to place these reports in a relevant storage location and just update all the technical data references to point at that report. However, you really need to take additional time to ensure issues don’t arise at a later date.

Report review

Review the report to confirm the following are correct:

  1. Model numbers noted in the report
  2. Critical components shown are correct and correct part number is noted (for example make sure numbers did not get flipped in the part number)
  3. The standard and edition match expectations
  4. Testing conducted matches what was expected
  5. Certifications requested match what is received

While reviewing the report for errors is critical, the review will help you understand what was evaluated and items to consider as the product changes. As most products undergo changes to add features or parts are replaced/updated, the report can provide a road map to what needs to be considered when something changes. 

Critical component awareness

During your review of the documentation, you need to be aware of items considered critical with regard to the test report. A change in type or a specific model of a part can affect the test results documented. For example, if at a later date you need to change an internal power supply for a new one with the same ratings, the report can provide information on items that are critical to the evaluation. On the surface, it seems like a simple replacement of the new internal power supply. However, a review of the report can identify the insulation required in the supply and point out temperatures previously measured during the evaluation. This information gives you a starting point to understand that a new internal power supply will likely require testing. Reviewing other information may point out testing that needs to be conducted.

Spending time to understand the details in your report is strongly recommended. When questions arise or if you need more explanation, our experts are available to address your concerns. 


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