{"id":1853,"date":"2022-12-20T07:09:24","date_gmt":"2022-12-20T07:09:24","guid":{"rendered":"https:\/\/operonstrategist.com\/oman\/?page_id=1853"},"modified":"2025-07-07T09:43:51","modified_gmt":"2025-07-07T09:43:51","slug":"mdsap","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-om\/services\/turnkey-project-consultants\/quality-management-system\/mdsap\/","title":{"rendered":"MDSAP"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1853\" class=\"elementor elementor-1853\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-52d616b7 banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"52d616b7\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-51420fe3\" data-id=\"51420fe3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e6b9c19 banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"3e6b9c19\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">MDSAP - Medical Device Single Audit Program<\/h1>\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e951e22 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e951e22\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ce3789b\" data-id=\"ce3789b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e00afa3 elementor-widget elementor-widget-heading\" data-id=\"e00afa3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is MDSAP?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-90edfc2 elementor-widget elementor-widget-text-editor\" data-id=\"90edfc2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-family: georgia, palatino; font-size: 12pt;\">MDSAP is a Medical Device Single Audit Program that allows the conduct of single regulatory audit of medical device manufacturer\u2019s QMS that satisfies various regulatory jurisdiction. This program was developed by a group of medical device regulators, the IMDRF, to allow the third-party auditors to conduct this single audit of medical device manufacturers which covers\u00a0<a href=\"https:\/\/operonstrategist.com\/en-om\/services\/turnkey-project-consultants\/quality-management-system\/iso-13485-qms-medical-device\/\" target=\"_blank\" rel=\"noopener\">ISO13485:2016<\/a>\u00a0and respective regulatory requirement.\u00a0<\/span><\/p><p><span style=\"font-family: georgia, palatino; font-size: 12pt;\">MDSAP is a mechanism for producers of medical devices to have their compliance with the standards and laws of up to five distinct medical device markets, including Australia, Brazil, Canada, Japan, and the United States, audited once. The goal of MDSAP is to make it possible to conduct a single regulatory audit of a medical device manufacturer\u2019s quality management system.\u00a0<\/span><\/p>\t\t\t\t\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8139a49 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8139a49\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f207135\" data-id=\"f207135\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-0aea3fa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0aea3fa\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-d54f154\" data-id=\"d54f154\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-276e93e elementor-widget elementor-widget-heading\" data-id=\"276e93e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What Regulatory Authorities Included in MDSAP?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-baf2b6c elementor-widget elementor-widget-text-editor\" data-id=\"baf2b6c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Australia (TGA:\u00a0Therapeutic Goods Administration of Australia)\u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Brazil (ANVISA:\u00a0Brazil\u2019s Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria)\u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Canada (Health CANADA)\u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Japan (MHLW:\u00a0Japan\u2019s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency)\u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">USA (FDA: Food and Drug Administration)\u00a0<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bebfbda elementor-widget elementor-widget-heading\" data-id=\"bebfbda\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What are the Benefits of MDSAP Certification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e180a3 elementor-widget elementor-widget-text-editor\" data-id=\"9e180a3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\">Time-saving and efficiency \u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\">Clarity and transparency\u00a0\u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\">Reduces the number of audits and inspections\u00a0<\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"2\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Reliable audit schedule<\/span><\/li><\/ul>\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-829a6a8\" data-id=\"829a6a8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-321d9af elementor-widget elementor-widget-image\" data-id=\"321d9af\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1530\" height=\"1536\" src=\"https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1.jpg\" class=\"attachment-2048x2048 size-2048x2048 wp-image-1883\" alt=\"MDSAP\" srcset=\"https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1.jpg 1530w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-300x300.jpg 300w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-1020x1024.jpg 1020w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-150x150.jpg 150w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-768x771.jpg 768w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-500x502.jpg 500w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-800x803.jpg 800w, https:\/\/operonstrategist.com\/en-om\/wp-content\/uploads\/2022\/12\/MDSAP-01-01-1530x1536-1-1280x1285.jpg 1280w\" sizes=\"(max-width: 1530px) 100vw, 1530px\" \/>\t\t\t\t\t\t\t\t\t\t\t\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-669d206 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"669d206\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-626d038\" data-id=\"626d038\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-140fa42 elementor-widget elementor-widget-heading\" data-id=\"140fa42\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">MDSAP and ISO13485<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dc61075 elementor-widget elementor-widget-text-editor\" data-id=\"dc61075\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-family: georgia, palatino; font-size: 12pt;\"><span class=\"TextRun SCXW58190761 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW58190761 BCX0\">MDSAP has more stringent requirement than ISO13485.<\/span>\u00a0<span class=\"NormalTextRun SCXW58190761 BCX0\">ISO 13485 and MDSAP two different progra<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">ms<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">\u00a0with similar\u00a0<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">requirement.\u00a0<\/span><\/span><span class=\"TextRun SCXW58190761 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW58190761 BCX0\">the devices are used in the healthcare industry and pharma industry with the end users being humans so ISO13485 MDSAP standards look to ensure that\u00a0<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">medical<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">\u00a0device\u00a0<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">manufactured to strict quality requirements.\u00a0<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">Companies that participate in the MDSAP\u00a0<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">program<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">\u00a0must undergo an audit to ensure compliance with both regulatory and ISO 13485 requirements in order to profit from the\u00a0<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">program<\/span><span class=\"NormalTextRun SCXW58190761 BCX0\">.<\/span><\/span><\/span><\/p>\t\t\t\t\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-940e01c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"940e01c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-80ea4b6\" data-id=\"80ea4b6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-455958a elementor-widget elementor-widget-heading\" data-id=\"455958a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">How Operon Strategist Help in MDSAP Certification Process?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e832493 elementor-widget elementor-widget-text-editor\" data-id=\"e832493\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span style=\"font-family: georgia, palatino; font-size: 12pt;\"><b>Defining the goals<\/b>:\u00a0 To start with the first step we discuss with you about the company and the benefit of MDSAP certification. You will receive a specific offer tailored to the need of your company or organization \u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span style=\"font-family: georgia, palatino; font-size: 12pt;\"><b>Project planning:<\/b>\u00a0project planning is the step where we do a pre-audit, which helps us to identify the improvement potential of QMS in advance. This pre-audit meeting helps us in planning and scheduling the audit procedures.\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span style=\"font-family: georgia, palatino; font-size: 12pt;\"><b>QMS Quality Management System Assessment<\/b>:\u00a0 while assessing this step we guide and provide training to our clients to implement QMS as per the required regulations and we also help them in the creation of documents.\u00a0<\/span><\/li><li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"3\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span style=\"font-family: georgia, palatino; font-size: 12pt;\"><strong>System evaluation:<\/strong>\u00a0You acquire your MDSAP certificate if all requirements are satisfied and the assessor\u2019s recommendation for certification is confirmed.\u00a0<\/span><\/li><\/ul><p><span style=\"font-family: georgia, palatino; font-size: 12pt;\">The cost for the<a href=\"https:\/\/operonstrategist.com\/mdsap-faq\/\" target=\"_blank\" rel=\"noopener\">\u00a0MDSAP<\/a> certification depends on the country-specific requirements that need to be assessed during the audit.<\/span><\/p><div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-107de224 animated-slow animated fadeInDown\" data-id=\"107de224\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;animation&quot;:&quot;fadeInDown&quot;}\"><div class=\"elementor-widget-wrap elementor-element-populated\">\u00a0<\/div><\/div>\t\t\t\t\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2881290 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2881290\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-dcc5976\" data-id=\"dcc5976\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a0ce4ca elementor-widget elementor-widget-heading\" data-id=\"a0ce4ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Operon Strategist Provides MDSAP Consultancy Services in Worldwide<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7e75900 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7e75900\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-456f473\" data-id=\"456f473\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6e7ec8a elementor-widget elementor-widget-text-editor\" data-id=\"6e7ec8a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\"><a href=\"https:\/\/operonstrategist.com\/en-sa\/services\/turnkey-project\/quality-management-system\/fda-21-cfr-part820\/\"><strong>Saudi Arabia<\/strong><\/a><br \/><a href=\"https:\/\/operonstrategist.com\/en-cr\/services\/turnkey-project-consultants\/mdsap\/\"><strong>Costa Rica<\/strong><\/a><br \/><a href=\"https:\/\/us.operonstrategist.com\/services\/mdsap-certification\/\"><strong>US<\/strong><\/a><\/p>\t\t\t\t\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<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-0e1c364\" data-id=\"0e1c364\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0b7812d elementor-widget elementor-widget-text-editor\" data-id=\"0b7812d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\"><a href=\"https:\/\/operonstrategist.com\/en-gb\/services\/turnkey-project-consultants\/mdsap\/\"><strong>UK<\/strong><\/a><br \/><a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/mdsap\/\"><strong>India<\/strong><\/a><br \/><a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/turnkey-project-consultants\/quality-management-system\/mdsap\/\"><strong>Egypt<\/strong><\/a><\/p>\t\t\t\t\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<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-821f9f0\" data-id=\"821f9f0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3b604d6 elementor-widget elementor-widget-text-editor\" data-id=\"3b604d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\"><strong><a href=\"#\">South Africa<\/a><br \/><a href=\"https:\/\/operonstrategist.com\/en-nl\/services\/turnkey-project-consultants\/clean-room-guidance\/\">Netherlands<\/a><br \/><a href=\"https:\/\/operonstrategist.com\/en-de\/services\/turnkey-project-consultants\/mdsap\/\">Germany<\/a><br \/><\/strong><\/p>\t\t\t\t\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<div class=\"elementor-column elementor-col-25 elementor-inner-column elementor-element elementor-element-f8f14c8\" data-id=\"f8f14c8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0b1f0b9 elementor-widget elementor-widget-text-editor\" data-id=\"0b1f0b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: center;\"><a href=\"https:\/\/operonstrategist.com\/en-om\/services\/turnkey-project-consultants\/quality-management-system\/mdsap\/\"><strong>Oman<\/strong><\/a><br \/><a href=\"https:\/\/operonstrategist.com\/en-ir\/services\/turnkey-project-consultants\/mdsap\/\"><strong>Iran<\/strong><\/a><\/p>\t\t\t\t\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\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>MDSAP &#8211; Medical Device Single Audit Program What is MDSAP? MDSAP is a Medical Device Single Audit Program that allows the conduct of single regulatory audit of medical device manufacturer\u2019s QMS that satisfies various regulatory jurisdiction. This program was developed by a group of medical device regulators, the IMDRF, to allow the third-party auditors to [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":32,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_vp_format_video_url":"","_vp_image_focal_point":[],"footnotes":""},"class_list":["post-1853","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/pages\/1853","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/comments?post=1853"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/pages\/1853\/revisions"}],"predecessor-version":[{"id":3420,"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/pages\/1853\/revisions\/3420"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/pages\/32"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-om\/wp-json\/wp\/v2\/media?parent=1853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}