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Regulatory Challenges for Software as Medical Device or ... · must be validated according to the state of the art taking ... (MEDDEV-Guideline 2.12-1 rev 8, January 2013) European
MEDDEV 2.7/1 revision 4, Clinical evaluation: a guide for ... › sites › default › files › eu-meddev-2_7_… · [derived from Article 1.2.k MDD and Art. 1.2.k AIMDD] Clinical
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Council of the European Union Interinstitutional Files ... · MEDDEV 2.12-1, rev. 8. 12 DS 2046/13 DE add ... manufacturer’s quality management system according to Article 8, paragraph
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