Vigilance process : class IIa custom-made devices
Granbåge, Niko (2024)
2024
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Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:amk-2024102726873
https://urn.fi/URN:NBN:fi:amk-2024102726873
Tiivistelmä
The legislation outlines the requirements related to the mandatory process for reportable events. The process was established as one of the obligations of manufacturers. Over time, this mandatory process became ever more detailed. This process was later referred to as "vigilance".
The main objective of this thesis was to characterize the vigilance process. Another objective was to investigate whether voluntary concepts could be integrated into the mandatory process. This thesis was a development work. The Define phase of the DMAIC cycle guided the development work.
The results of this thesis characterized the process. Voluntary concepts were integrated into the mandatory process. The process was characterized to consider also other than mandatory reportable events. The process was characterized by producing swimlane diagrams. These diagrams were included in the appendices.
The main objective of this thesis was to characterize the vigilance process. Another objective was to investigate whether voluntary concepts could be integrated into the mandatory process. This thesis was a development work. The Define phase of the DMAIC cycle guided the development work.
The results of this thesis characterized the process. Voluntary concepts were integrated into the mandatory process. The process was characterized to consider also other than mandatory reportable events. The process was characterized by producing swimlane diagrams. These diagrams were included in the appendices.