Recorded version: Webinar on ANSI C63.27 and coexistence testing for medical devices

In this webinar, we will give an introduction to ANSI C63.27 and the specifications anchored in it.

The topic of coexistence has been explicitly relevant to approval in the USA since 2017: Since then, there has been a test specification ANSI C63.27: “American National Standard for Evaluation of Wireless Coexistence”. The FDA requires the evaluation of the behavior of medical devices that contain wireless modules and are to be used in an environment where other wireless systems are already active. This applies, for example, to all devices that are to be used in hospitals in the USA. The aim is to determine a “LOC” (likelihood of coexistence).

In our webinar, we address this topic and go into detail about the practical implementation of relevant tests and the evaluation of the results. We will explain what makes this “very atypical” test standard so challenging. The various test set-ups are discussed and a typical presentation of results is explained. Practical examples are shown and it is also explained which formal aspects are important to the FDA. In addition, there is also a brief explanation of what has changed in the 2021 version compared to the 2017 version and which topics are under discussion for future versions.

The webinar that originally took place on January 30, 2025, is offered in two language versions.

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