Template

List of Known Anomalies

Sven Piechottka · IEC 62304 Templates · Published November 01, 2023

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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 62304:2006 Para. 5.7.5, 5.8.2 / 5.8.3

Anomalies

Title Description Impact / Hazard Discovery (Date, How, By Whom) Proposed Correction Justification for Delay Timeline
Default language 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. 2022-04-01 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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Sven Piechottka

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

 I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.
More about me