{"id":333371,"date":"2025-05-26T16:03:30","date_gmt":"2025-05-26T20:03:30","guid":{"rendered":"https:\/\/interfacing.com\/conformite-a-la-norme-21-cfr-part-820-pour-les-dispositifs-medicaux"},"modified":"2025-05-27T14:11:38","modified_gmt":"2025-05-27T18:11:38","slug":"conformite-fda-21-cfr-part-820","status":"publish","type":"page","link":"https:\/\/interfacing.com\/fr\/conformite-fda-21-cfr-part-820","title":{"rendered":"Conformit\u00e9 \u00e0 la norme 21 CFR Part 820 pour les dispositifs m\u00e9dicaux"},"content":{"rendered":"\t\t
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\nConformit\u00e9 \u00e0 la norme 21 CFR Part 820 pour les dispositifs m\u00e9dicaux<\/h2>
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Please Select contact form.<\/p><\/div> <\/div>\n

\n\n\nAssurez-vous que la conception, la production et la surveillance post-commercialisation sont conformes \u00e0 la FDA gr\u00e2ce \u00e0 des syst\u00e8mes qualit\u00e9 propuls\u00e9s par l\u2019IA.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

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Qu\u2019est-ce que la norme 21 CFR Part 820?<\/h2>\t\t\r\n\t<\/div>\r\n<\/div>\r\n\r\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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La norme 21 CFR Part 820, \u00e9galement connue sous le nom de Quality System Regulation (QSR), est un r\u00e8glement de la Food and Drug Administration (FDA) des \u00c9tats-Unis qui d\u00e9finit les Bonnes Pratiques de Fabrication (CGMP) applicables aux fabricants de dispositifs m\u00e9dicaux. Ces r\u00e8gles r\u00e9gissent la conception, le contr\u00f4le et la tra\u00e7abilit\u00e9 des dispositifs afin de garantir leur s\u00e9curit\u00e9 et leur efficacit\u00e9 tout au long de leur cycle de vie.\n

\nIntroduit initialement en 1996 et mis \u00e0 jour pour s\u2019aligner avec la norme ISO 13485:2016, ce r\u00e8glement constitue la pierre angulaire de la conformit\u00e9 FDA pour les dispositifs m\u00e9dicaux de classe I, II et III commercialis\u00e9s aux \u00c9tats-Unis.\n

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