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Updated December 8, 2021

Template: List of Known Anomalies

Sven Piechottka
IEC 62304

This is a free template, provided by OpenRegulatory.

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List of Known Anomalies

This template is supposed to give you an idea of the structure. Don’t use Microsoft Word - this is thought as an excel / sheets file.

This list shows technical errors (“bugs”) of the current device which were decided not be corrected before the release of the latest version.

It therefore serves as an overview and as a documentation of reasoning for non-correction.

Anomalies

Title Description Impact / Hazard Discovery (Date, How, By Whom) Proposed Correction Justification for Delay Timeline
Default lanaguage If the app is installed on a smartphone with unsupported language, the default language is German. Users then have to navigate to the language settings for changes. Users in countries with unsupported language are likely not German-speaking and may not be able to use the app without changing language settings. 01-04-2021 during usability testing by Product Manager Change default language to English Per appstore setting, the app is currently only available in countries whose predominant language is supported. Next version release
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