{"id":7030,"date":"2023-11-30T02:48:35","date_gmt":"2023-11-30T02:48:35","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7030"},"modified":"2024-01-11T16:47:43","modified_gmt":"2024-01-11T16:47:43","slug":"medical-device-qms-overview","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/medical-device-qms-overview\/","title":{"rendered":"Medical Device QMS 101: What It Is, Where It\u2019s Required, and Key Regulations to Know"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7030\" class=\"elementor elementor-7030\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_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-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\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-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2023\/11\/30\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tNovember 30, 2023\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Medical Device QMS 101: What It Is, Where It\u2019s Required, and Key Regulations to Know<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>In this article:<\/strong><\/p><p><a href=\"#regulations\"><u>Regulations Governing a Medical Device QMS<\/u><\/a><br \/><a href=\"#relationship\"><u>Relationship Between Medical Device Approval and Your QMS<\/u><\/a><br \/><a href=\"#key\"><u>Key Components of a Quality Management System that Meets US FDA and EU Requirements<\/u><\/a><br \/><a href=\"#developing\"><u>Developing a Medical Device QMS<\/u><\/a><br \/><a href=\"#understanding\"><u>Understanding Key Obligations in ISO 13485:2016 and the US FDA QSR<\/u><\/a>\u00a0<\/p><p>\u00a0<\/p><p>Let\u2019s start with the basics. In simple terms, a medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more. Most medical devices will require some form of a QMS; the complexity of the QMS will vary based on the classification of the device. For example, companies making medium-risk (Class II) or high-risk devices (Class III) devices will require a different QMS implementation than companies making low-risk devices (Class I). We won\u2019t get into the specifics of product registration or classification, but you will want to understand the classification of your devices before building a QMS.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-47a3899 elementor-widget elementor-widget-image\" data-id=\"47a3899\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2809\" height=\"1415\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS_Areas.png\" class=\"attachment-full size-full wp-image-734\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS_Areas.png 2809w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS_Areas-300x151.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS_Areas-768x387.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS_Areas-1024x516.png 1024w\" sizes=\"(max-width: 2809px) 100vw, 2809px\" \/>\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<div class=\"elementor-element elementor-element-859438a elementor-widget elementor-widget-menu-anchor\" data-id=\"859438a\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\nbody.elementor-page .elementor-widget-menu-anchor{margin-bottom:0}<\/style>\t\t<div id=\"regulations\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Regulations Governing a Medical Device QMS<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" data-element_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<p>Nearly every major market requires the implementation and maintenance of a quality management system as a condition of product registration. Device manufacturers in Europe tend to follow the ISO 13485 standard, while US companies comply with the US FDAs Quality System Regulation (QSR).<\/p><h4>\u00a0<\/h4><h4>What\u2019s the difference?<\/h4><p>\u00a0<\/p><p>ISO 13485 is an international quality management system standard followed by companies selling in Europe, Canada, Australia, and other markets. Except for Canada, application of ISO 13485 is not actually required, but it is the de facto means by which most companies comply with the specific QMS requirements set forth in national medical device regulations.<\/p><p>The US has its own set of regulations for medical device companies. The US FDA QSR, also known by its US regulation number 21 CFR Part 820, preceded the original publication of ISO 13485. US medical device companies that distribute their products internationally need to meet the requirements of both. Similarly, countries outside the US that distribute products in the US must also comply with US FDA 21 CFR Part 820.<\/p><p>Other countries such as Brazil and Japan have their own nuanced QMS requirements, but those are based on ISO 13485 or the FDA QSR. The good news is that many of the requirements of ISO 13485 and the FDA QSR are very similar. As such, companies can have a single, harmonized quality management system that meets US, Canadian, European, and any other regulatory QMS requirements. Harmonizing disparate quality management systems into one integrated system may seem daunting but in the long run the effort is well worth it. We will talk about the requirements of ISO 13485 and FDA QSR in more detail later.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-993c3b6 elementor-widget elementor-widget-menu-anchor\" data-id=\"993c3b6\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"relationship\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Relationship Between Medical Device Regulatory Approval and Your QMS<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_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<p>You may wonder what a QMS has to do with getting approval for your product(s) from the US FDA or obtaining CE Marking in the European Union. They are inextricably linked. The US FDA requires compliance with 21 CFR Part 820 at the time your product is registered with FDA. The majority of companies making medium-risk devices will go through the 510(k) process. When you submit your 510(k), you are expected to be in compliance with 21 CFR Part 820. Ironically, although QSR compliance is required, FDA does not require proof of compliance when registering your Class I or Class II device. Why? The US FDA enforces compliance through random inspections. As such, FDA inspectors may come knocking on the door of the manufacturer of a newly registered medical device at any time. If you are not fully prepared, you won\u2019t like the consequences.<\/p><p>It\u2019s a different process in most European countries, where you need to obtain CE Marking for the device as a condition of distribution. If you are seeking to obtain CE Marking for anything other than a Class I non-sterile, non-measuring, non-reusable surgical instrument device, you cannot get CE Marking without proving you meet the requirements of Article 10 (General obligations of manufacturers) and Annex IX (Conformity assessment based on QMS and technical documentation) of the new EU Medical Device Regulations (EU MDR). The most common way companies meet the requirements of Article 10 and Annex IX is through third-party certification to ISO 13485. Third-party certification is conducted by auditing organizations known as Notified Bodies (NBs). We should note that there are other ways to meet European QMS requirements, including the requirements listed in Annexes X (Conformity assessment based on type examination) and XI (Conformity assessment based on product conformity verification).<\/p><p>Finally, Health Canada (the Ministry of Health) requires conformance to ISO 13485:2016 through MDSAP certification. If you have plans to sell in Canada, you will need to implement a QMS compliant with ISO 13485:2016.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ef6f46 elementor-widget elementor-widget-menu-anchor\" data-id=\"7ef6f46\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"key\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b42d2b2 elementor-widget elementor-widget-heading\" data-id=\"b42d2b2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Key Components of a Quality Management System that Meets US FDA and EU Requirements<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81761d3 elementor-widget elementor-widget-text-editor\" data-id=\"81761d3\" data-element_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<p>We\u2019ve established that, as a medical device company, you need to implement a QMS and be in compliance with FDA 21 CFR Part 820 and\/or ISO 13485:2016. As noted, ISO 13485 is not required in most parts of the world but certainly is the \u201cde facto\u201d means of meeting QMS requirements in many countries. Let\u2019s talk about the entities with a role in maintaining, auditing, and certifying quality systems, starting with the US.<\/p><h4>\u00a0<\/h4><h4>US FDA and CDRH<br \/><br \/><\/h4><p>Within the Food and Drug Administration (FDA) is the Center for Devices and Radiological Health. This division \u2013 commonly known as CDRH \u2013 oversees the regulation of most medical devices that do not have a pharmaceutical or biological component. When you register your company with the US FDA (establishment registration usually is done when you also register your first device), you will be on the \u201cradar\u201d of CDRH inspectors. As mentioned earlier, the FDA conducts its own inspections and holds the legal authority to prevent or stop companies from selling their products in the US market.<\/p><h4>\u00a0<\/h4><h4>European Notified Bodies<\/h4><p>\u00a0<\/p><p>European Notified Bodies are supervised by the Competent Authorities of a particular EU member state to conduct inspections of medical device manufacturers. You\u2019ll find a list of notified bodies which can assess the conformity of medical device products listed in the NANDO database. Even though Notified Bodies are not government agencies, they do have the power to grant or deny ISO certification and\/or CE Marking for your device. In Canada, these are called Registrars, but nearly all Registrars are also Notified Bodies. Under the MDSAP scheme, Registrars are referred to as Auditing Organizations.<\/p><p>If you are studying medical device quality management system compliance, you also might run across the terms\u00a0<em>Authorized Representative\u00a0<\/em>(Europe),\u00a0<em>Sponsor\u00a0<\/em>(Australia),\u00a0<em>D-MAH\u00a0<\/em>(Japan), and\u00a0<em>US Agent<\/em>. If you are a US company selling in Europe, for example, and you don\u2019t have a local office there, you need to appoint a regulatory representative in that country (or countries). Regulatory representatives don\u2019t really play a role in the management or inspection of your quality system, but Notified Bodies will most certainly check to make sure you have one during their audits.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c6bc1aa elementor-widget elementor-widget-menu-anchor\" data-id=\"c6bc1aa\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"developing\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2772cd8 elementor-widget elementor-widget-heading\" data-id=\"2772cd8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Developing a Medical Device QMS <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12ec9d5 elementor-widget elementor-widget-text-editor\" data-id=\"12ec9d5\" data-element_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<p>If you are wondering where to start in putting together a quality management system for your organization, here are the basic phases.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-677 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS-Phase-Workflow-674w.png\" alt=\"QMS Workflow\" width=\"674\" height=\"328\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS-Phase-Workflow-674w.png 674w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/QMS-Phase-Workflow-674w-300x146.png 300w\" sizes=\"(max-width: 674px) 100vw, 674px\" \/><\/p><h4>\u00a0<\/h4><h4>\u00a0<\/h4><h4>A Quality Management System Is Evolutionary, Not Revolutionary<\/h4><p>While regulatory imperative is the driving force behind the creation of a quality management system, the QMS is not a set of procedures that get stored on a hard drive only to be opened when inspectors arrive. If you are doing things correctly, your QMS should help your business to be successful and evolve over time. Processes will be added, refined, or eliminated. The QMS should be built using a process approach (thus enabling the organization to plan processes and their interactions) and incorporate a risk-based approach and the PDCA cycle.<\/p><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-678 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/Do-Check-Act-Plan-674w.png\" alt=\"PDCA Cycle\" width=\"674\" height=\"436\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/Do-Check-Act-Plan-674w.png 674w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2018\/06\/Do-Check-Act-Plan-674w-300x194.png 300w\" sizes=\"(max-width: 674px) 100vw, 674px\" \/><\/p><p>\u00a0<\/p><p>The PDCA cycle enables your organization to ensure that its processes are resourced adequately, managed in practice, and analyzed for improvement opportunities that may be acted upon. Coupling a risk-based approach with your process management activities enables your organization to determine the factors that could cause your processes and QMS to deviate from the planned results. Coupling these two approaches will help your organization put preventive measures in place to minimize negative outcomes.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-da5ac8c elementor-widget elementor-widget-menu-anchor\" data-id=\"da5ac8c\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"understanding\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1022d41 elementor-widget elementor-widget-heading\" data-id=\"1022d41\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Understanding Key Obligations in ISO 13485:2016 and the US FDA QSR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7a0113 elementor-widget elementor-widget-text-editor\" data-id=\"c7a0113\" data-element_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<p>We can\u2019t cover all aspects of the ISO 13485:20216 standard and 21 CFR Part 820 regulation in this discussion, so we will focus on five key areas:<\/p><ul><li>Document control<\/li><li>Management responsibility<\/li><li>Resource management<\/li><li>Product realization<\/li><li>Measurement analysis and improvement<\/li><\/ul><h4>\u00a0<\/h4><h4>QMS Document Control<br \/><br \/><\/h4><p>A QMS cannot function without solid\u00a0<strong>document control<\/strong>. Section 4.2 and other specific sections of ISO 13485:2016 outline your obligations, and so do various subparts of the FDA QSR, as indicated below. There are several important documents you must maintain \u2013 this is only a partial list:<\/p><ul><li><strong>Quality manual\u00a0<\/strong>(ISO 13485:2016 section 4.2.2) \u2013 Provides an overall guide to your QMS and defines key information like the scope of your system. Your quality manual can serve as a guide to the system for an outside auditor. A quality manual is not required by FDA but is highly recommended to help summarize your QMS.<\/li><li><strong>Design history file\u00a0<\/strong>(ISO 13485:2016 section 7.3.10, 21 CFR Part 820.30) \u2013 Covers the plans, requirements, design review records, and design verification results. You can think of this as the history of how you concocted the \u201crecipe\u201d for your device.<\/li><li><strong>Medical device file\u00a0<\/strong>(ISO 13485:2016 section 4.2.3, 21 CFR Part 820.181) \u2013 Documents that demonstrate your conformity to the standard and regulation, including device description, labeling, IFU, intended use, specifications for manufacturing, storage, packaging, and much more. FDA calls this the\u00a0<em>device master record<\/em>. This is the actual \u201crecipe\u201d for your device.<\/li><li><strong>Device history record\u00a0<\/strong>\u2013 (ISO 13485:2016 section 7.5.1, 21 CFR Part 820.184) \u2013 Requires you to maintain records of dates of manufacture, quantities manufactured, quantity released, lots, acceptance records, and more. This is your record of how you followed the \u201crecipe\u201d to produce your device.<\/li><\/ul><h4>\u00a0<\/h4><h4>Management Responsibility<\/h4><p><br \/>You may have excellent control over your records, but without the full support of executive management your QMS will not be effective at maintaining product safety and promoting continuous improvement of your processes. You\u2019ll notice that we used the word \u201cexecutive.\u201d FDA and the ISO standard are serious about this. FDA states in 820.12, \u201cManagement with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.\u201d<\/p><p>The primary difference between the QSR and ISO 13485 is that the standard emphasizes management responsibility in the context of meeting customer requirements in addition to regulatory requirements. The QSR is focused entirely on meeting requirements on design, manufacturing, distribution, and support of safe and effective medical devices. You will find the requirements for management responsibility in section 5 of ISO 13485:2016.<\/p><p>\u00a0<\/p><h4>Resource Management<\/h4><p><br \/>Section 6 of ISO 13485:2016 and subparts 820.20\/25\/70 deal with this topic, and touch on a variety of issues. Essentially, they require the company to identify the need for and to allocate qualified personnel, overall infrastructure, and work environment to ensure product safety. You also have an obligation to ensure the competency of your staff, which includes establishing formal competency and training procedures, maintaining records related to employee competency, and providing training as needed. Don\u2019t take these requirements lightly. FDA often finds that failure to comply with these subparts of the regulation leads to other significant regulatory violations.<\/p><h4>\u00a0<\/h4><h4>Product Realization<\/h4><p><br \/>Section 7 of ISO 13485:2016 is important, along with corresponding subparts of the FDA QSR. One of the more important areas covered here concerns your obligations to maintain design controls. While the objective of maintaining control over your product design (which includes software) is consistent between the ISO standard and the QSR, the standard applies to all medical devices whereas the QSR requires a design history file primarily for medium- and high-risk devices only.<\/p><p>Purchasing controls (21 CFR Part 820.50) are covered under product realization. This includes a requirement to document supplier controls, subcontractors, purchasing data, receiving, etc. The focus here is on ensuring that purchased product doesn\u2019t have a negative effect on the quality of your medical device.<\/p><p>Section 7.1 specifically requires the use of risk management in product realization and references a related standard, ISO 14971. If you are not already familiar with this standard, you\u2019ll need to be. Risk management is hugely important and is critical to ensuring a safe and effective device. The new European Medical Device Regulation also places much more emphasis on this topic.<\/p><p>Section 7.5 of ISO 13485:2016 on production and service provision covers topics including the acceptance criteria for products and parts, contamination control, installation, product servicing, and even particular requirements for sterile medical devices \u2013 all of the activities that you actually perform to make or deliver your device. Read 21 CFR Parts 820.70, 820.80, 820.170, and 820.200 for specific information on FDA requirements for these areas.<\/p><p>The topic of process validation could be its own book, but at a high level, here\u2019s what you need to know. Process validation is the process by which you establish objective evidence that a process consistently produces a result or product that meets predetermined specifications. Section 7.5.6 of the standard outlines the requirements along with 21 CFR Part 820.75. Validation requirements also apply to software you use throughout your processes.<\/p><p>Identification (section 7.5.8) and traceability (section 7.5.9) are also critical subsections of the standard and correlate with several sections of the QSR, including 820.60 and 820.65, respectively. The emphasis here is on making sure you know where your devices\/components came from, how they were distributed, and where they are now. This issue has become far more important in the last five years. The US FDA has specific requirements for unique device identification (UDI). The European Union soon will have similar requirements for device tracking, information that will be added to the new EUDAMED database which requires close monitoring for the official implementation date.<\/p><p>\u00a0<\/p><h4>Measurement, Analysis, and Improvement<\/h4><p><br \/>Of course, a quality management system would be worthless without an effective means of measuring its performance in meeting planned results.<\/p><p>Section 8 of 13485 covers this topic and outlines your responsibility to collect feedback on your QMS from various sources, properly handle customer complaints, conduct regular internal audits, deal with nonconforming products, analyze data, and establish an effective corrective and preventive action (CAPA) program. You\u2019ll find several sections of the QSR that take on these<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8471c6c elementor-widget elementor-widget-heading\" data-id=\"8471c6c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Final Note<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0644c8b elementor-widget elementor-widget-text-editor\" data-id=\"0644c8b\" data-element_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<p>Establishing a quality management system and understanding the differences between ISO 13485:2016 and the FDA Quality System Regulation can seem daunting. However, once you start to understand the principles behind the standard and the regulation, you will find plenty of overlap. We offer several ways to get started. Consider our <a href=\"https:\/\/www.orielstat.com\/courses\/FDA-QSR-training-21cfr820\">medical device QMS overview training<\/a>. 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Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device QMS 101: What It Is, Where It\u2019s Required, and Key Regulations to Know In this article: Regulations Governing a Medical Device QMSRelationship Between Medical Device Approval and Your QMSKey Components of a Quality Management System that Meets US FDA and EU RequirementsDeveloping a Medical Device QMSUnderstanding Key Obligations in ISO 13485:2016 and the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":740,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[14,4],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Medical Device QMS 101: What It Is, Where It\u2019s Required, and Key Regulations to Know<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" 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