{"id":6866,"date":"2026-06-10T17:21:16","date_gmt":"2026-06-10T11:51:16","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6866"},"modified":"2026-06-10T17:21:16","modified_gmt":"2026-06-10T11:51:16","slug":"common-non-conformities-to-mdsap-audit","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/gb-en\/common-non-conformities-to-mdsap-audit\/","title":{"rendered":"Common Non-conformities to MDSAP Audit"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6866\" class=\"elementor elementor-6866\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-59f2d654 e-flex e-con-boxed e-con e-parent\" data-id=\"59f2d654\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3c50f2d elementor-widget elementor-widget-heading\" data-id=\"3c50f2d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Common Non-conformities to MDSAP Audit<\/h1>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-48a0bf19 e-flex e-con-boxed e-con e-parent\" data-id=\"48a0bf19\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6751e5bc e-con-full e-flex e-con e-child\" data-id=\"6751e5bc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-24399dd6 elementor-widget elementor-widget-heading\" data-id=\"24399dd6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDSAP Audit\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2446da9e elementor-widget elementor-widget-text-editor\" data-id=\"2446da9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The Medical Device Single Audit Program (MDSAP) was formed by the International Medical Device Regulatory Forum (IMDRF) to adopt a global regulatory approach and promote consistency and transparency by harmonizing the program. It consists of ISO 13485:2016 and regulations and standards of 5 participating countries.<\/span><\/p><p><span style=\"font-weight: 400;\">You can check out our page on <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">MDSAP audit<\/span><\/a><span style=\"font-weight: 400;\"> to learn more about it.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">MDSAP observes various non-conformities while auditing. Continue reading to find out some of the common non-conformities found during MDSAP audits.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4874b3e5 e-con-full e-flex e-con e-child\" data-id=\"4874b3e5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-5cdb8e79 e-con-full e-flex e-con e-child\" data-id=\"5cdb8e79\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6dc51c44 elementor-widget elementor-widget-heading\" data-id=\"6dc51c44\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Talk to our medical device experts\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-53511f47 elementor-widget elementor-widget-wpforms\" data-id=\"53511f47\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/gb-en\/wp-json\/wp\/v2\/posts\/6866\" data-token=\"24a33a86f378ed1e881eb77b5877b2eb\" data-token-time=\"1781106976\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Paragraph Email Name<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6866\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-724126c3 e-flex e-con-boxed e-con e-parent\" data-id=\"724126c3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ad7f0b1 elementor-widget elementor-widget-heading\" data-id=\"2ad7f0b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Who Are the Participants in MDSAP?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f820b68 elementor-widget elementor-widget-text-editor\" data-id=\"1f820b68\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">MDSAP audits prove to be of great value to manufacturers as a single audit ensures compliance with the regulations of 5 different medical device markets. It is accepted by the following regulatory bodies:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Australia (TGA: Therapeutic Goods Administration of Australia).\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Brazil (ANVISA: Brazil\u2019s Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Canada (Health CANADA)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Japan (MHLW: Japan\u2019s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency)\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">USA (FDA: Food and Drug Administration).<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48b9139 elementor-widget elementor-widget-heading\" data-id=\"48b9139\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Common Non-conformities to MDSAP Audits\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a963d27 elementor-widget elementor-widget-text-editor\" data-id=\"a963d27\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Below are some non-conformities found while conduction audit:<\/span><\/p><ul><li><span style=\"font-weight: 400;\">Preparedness for Country specific requirements<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">While preparing the QMS documentation for MDSAP. The companies miss out on mentioning the country specific requirements.\u00a0\u00a0<\/span><\/p><ul><li><span style=\"font-weight: 400;\">Documentation errors<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">As per medical device experts, mostly non-conformances are found in this area. MDSAP audit will require you to demonstrate evidence of conformity to the program. Documentation is crucial to ensure this as it holds records of everything from product design to post-market activities.<\/span><\/p><ul><li><a href=\"https:\/\/operonstrategist.com\/risk-management-and-design-controls\/\"><span style=\"font-weight: 400;\">Risk management<\/span><\/a><\/li><\/ul><p><span style=\"font-weight: 400;\">Risk management was first introduced in ISO 13485:2016 to make organizations consider the risks involved in the design, development and manufacturing phases. MDSAP prioritizes risk and makes it an underlying element of all processes.<\/span><\/p><ul><li><span style=\"font-weight: 400;\">Purchase and supply control<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">With MDSAP\u2019s emphasis on purchasing, it has now become an underlying process for everything. You will now have to consider how purchasing will affect your supply chain and further the delivery of product to end customers.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-87880c0 elementor-widget elementor-widget-heading\" data-id=\"87880c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Tips for Successful MDSAP Audit\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb68619 elementor-widget elementor-widget-text-editor\" data-id=\"cb68619\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li><span style=\"font-weight: 400;\">Organize your documents<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Documents are crucial at all stages hence all the documents must be organized and made accessible for a successful audit. The audits are scheduled activity and the auditing organization (AO) will visit the site only once so make sure you are ready with all the documents before the audit.<\/span><\/p><ul><li><span style=\"font-weight: 400;\">Perform Gap analysis and internal audits<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">The auditing organizations and manufacturers who have gone through the MDSAP audits agree that using a <\/span><a href=\"https:\/\/medtech.pharmaintelligence.informa.com\/-\/media\/supporting-documents\/medtech-insight\/2020\/06\/mdsap-companion-document.pdf?rev=782efff3937c4f73a370df667f2d4117\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">MDSAP companion document<\/span><\/a><span style=\"font-weight: 400;\"> is the best way to prepare for the audit. An MDSAP companion document will help you create a gap analysis and perform an effective internal audit. The companion document is a handy supplement for manufacturers and will help them understand what areas the auditors will focus on.<\/span><\/p><ul><li><span style=\"font-weight: 400;\">Use the MDSAP audit model to determine AO needs<\/span><\/li><\/ul><p><a href=\"https:\/\/www.fda.gov\/media\/87544\/download\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">MDSAP audit model<\/span><\/a><span style=\"font-weight: 400;\"> is an AO\u2019s guide with all the information needed for the audit. All the questions that an AO will ask are listed in this comprehensive guide. And each question is aligned with relevant sections of ISO 13485:2016 and other specific requirements of participating medical device regulatories.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f2f48c elementor-widget elementor-widget-heading\" data-id=\"0f2f48c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Operon Strategist Can Help You Prepare for MDSAP Audit\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f80f5af elementor-widget elementor-widget-text-editor\" data-id=\"f80f5af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">MDSAP audits will make your medical device compliance-ready at the international level and in 5 prominent medical device markets. <\/span><a href=\"https:\/\/operonstrategist.com\/contact-us\/\"><span style=\"font-weight: 400;\">Contact us<\/span><\/a><span style=\"font-weight: 400;\"> for the right guidance for your MDSAP audit.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Operon Strategist is a medical device regulatory consulting firm that provides <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/cdsco-india\/\"><span style=\"font-weight: 400;\">CDSCO <\/span><span style=\"font-weight: 400;\">medical <\/span><span style=\"font-weight: 400;\">device registration<\/span><\/a><span style=\"font-weight: 400;\"> consultancy services and <\/span><a href=\"https:\/\/operonstrategist.com\/choosing-the-right-agency-for-iso-13485-certification\/\"><span style=\"font-weight: 400;\">ISO 13485 certification consultancy services<\/span><\/a><span style=\"font-weight: 400;\">. Contact us today and let our expert team guide you toward successful regulatory approvals.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MDSAP Audit The Medical Device Single Audit Program (MDSAP) was formed by the International Medical Device Regulatory Forum (IMDRF) to adopt a global regulatory approach and promote consistency and transparency by harmonizing the program. It consists of ISO 13485:2016 and regulations and standards of 5 participating countries. You can check out our page on MDSAP [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":12729,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[56],"tags":[],"class_list":["post-6866","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qms"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6866","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/comments?post=6866"}],"version-history":[{"count":1,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6866\/revisions"}],"predecessor-version":[{"id":12730,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/posts\/6866\/revisions\/12730"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media\/12729"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/media?parent=6866"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/categories?post=6866"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/gb-en\/wp-json\/wp\/v2\/tags?post=6866"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}