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Guidance Document: Software as a Medical Device (SaMD): Classification Examples
Conclusion: An erroneous result would not lead to immediate danger.Therefore, Class II is appropriate. Refer to section 2.3.2 of the Guidance Document – Software as a Medical Device (SaMD): Definition ...
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Guidance Document: Guidance on supporting evidence to be provided for new and amended licence applications for Class III and Class IV medical devices, not including In Vitro ...
The purpose of this guidance document is to elaborate on the scientific and clinical content to be included in Class III and Class IV (non-IVDD) medical device licence applications and medical device ...