{"id":32828,"date":"2024-07-18T16:13:22","date_gmt":"2024-07-18T14:13:22","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=32828"},"modified":"2024-07-18T17:17:13","modified_gmt":"2024-07-18T15:17:13","slug":"mdsap-requirements-for-the-united-states-fda","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2024\/07\/18\/mdsap-requirements-for-the-united-states-fda\/","title":{"rendered":"MDSAP: Requirements for the United States (FDA)"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>Thanks to the MDSAP (Medical Device Single Audit Programme), it is possible to access multiple markets with a single audit. This white paper provides an overview of MDSAP requirements with specific reference to the United States.<\/h2>\n<\/div>\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f32832-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"32832\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/posts\/32828#wpcf7-f32832-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"32832\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.1\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f32832-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input 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value=\"Greenland\">Greenland<\/option><option value=\"Guadeloupe\">Guadeloupe<\/option><option value=\"Guam\">Guam<\/option><option value=\"Guatemala\">Guatemala<\/option><option value=\"Guinea\">Guinea<\/option><option value=\"Guinea-Bissau\">Guinea-Bissau<\/option><option value=\"Equatorial Guinea\">Equatorial Guinea<\/option><option value=\"Guyana\">Guyana<\/option><option value=\"French Guiana\">French Guiana<\/option><option value=\"Haiti\">Haiti<\/option><option value=\"Honduras\">Honduras<\/option><option value=\"Hong Kong\">Hong Kong<\/option><option value=\"India\">India<\/option><option value=\"Indonesia\">Indonesia<\/option><option value=\"Iran\">Iran<\/option><option value=\"Iraq\">Iraq<\/option><option value=\"Bouvet Island\">Bouvet Island<\/option><option value=\"Christmas Island\">Christmas Island<\/option><option value=\"Heard Island and McDonald Islands\">Heard Island and McDonald Islands<\/option><option value=\"Cayman Islands\">Cayman Islands<\/option><option 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