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MDCG 2019-11

MDCG 2019-11

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9. Annex I: Illustrative examples of qualification of software used in the healthcare environment 18 10. Annex II - Qualification examples of Medical Device Software (MDSW) according to Figures 1 and 2 24 11. Annex III - Usability of the IMDRF risk classification framework in the context of the MDR 26 12. Annex IV – Classification examples 27

  Qualification

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