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Draft
IMDRF/SaMD WG/N81 DRAFT: 2024
Medical Device Software:
Considerations for Device and
Risk Characterization
AUTHORING GROUP
IMDRF Software as a Medical Devic
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PA\1270763EN.docx PE740.773v01-00
EN United in diversity EN
European Parliament
2019-2024
Committee on the Internal Market and Consumer Protection
2022/0140(COD)
8.2.2023
DRAFT OPINION
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European Parliament
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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
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Bundesgesetzblatt
Teil I
2023 Ausgegeben zu Bonn am 21. Dezember 2023 Nr. 380
Verordnung
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Auf Grun
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Guidance to CoBRA®/EViSiMa® VS Reports, V05 (valid from Q II 2020) Page 1 of 14
Guidance to CoBRA®/EViSiMa® VS Reports
This guidance concerns only reports for which the service “EViSiMa® VS
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