Template: List of Known Anomalies

Sven Piechottka
Updated April 26, 2024
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This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then opening the relevant folder to find this template ready to load into Formwork.

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The template license applies (don’t remove the copyright at the bottom, don’t re-use this for commercial purposes).

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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 to be corrected before the release of the latest version.

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

Regulatory references:

IEC 62304:2006Para. 5.7.5, 5.8.2 / 5.8.3

Anomalies

TitleDescriptionImpact / HazardDiscovery (Date, How, By Whom)Proposed CorrectionJustification for DelayTimeline
Default languageIf 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.2022-04-01 during usability testing by Product ManagerChange default language to EnglishPer appstore setting, the app is currently only available in countries whose predominant language is supported.Next version release
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