Characterization Test Report

Phase 2

What is a Characterization Test Report?

The purpose of a characterization test report in device development is to record/report the outcomes of a characterization protocol, or official procedure/framework for how a study, test, software etc. will be performed. It can have a very similar framework to its respective protocol but does not need to go into as much detail for the testing or reporting rationale sections. In addition, the report should include all pertinent testing results and statistical analysis that were used to lead to a conclusion or result of the testing.

Tips for Writing a Characterization Test Report:

Writing a Characterization Test Report for a medical device requires attention to detail and adherence to regulatory standards. Below are tips to help you make progress in the right direction.

Define the scope and objectives—clearly state the boundaries of the test report and the goals you want to achieve.
Clearly define the results of the testing—leave no ambiguity in describing what would be deemed a “positive” or “passing” test result.

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GOT QUESTIONS?

FAQ About Characterization Testing

Here are some answers to frequently asked questions about Characterization Testing.

What are common challenges in medical device characterization

How often is characterization testing performed?

What documentation is required for characterization testing?

How do manufacturers ensure the reproducibility of characterization testing?

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