[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” background_enable_color=”off” background_enable_image=”off” background_position=”center_right” background_blend=”multiply” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22%93}”][et_pb_fullwidth_header title=”FAQ” button_one_text=”Contact us” button_one_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjQyMyJ9fQ==@” logo_image_url=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/FAQ-icon1-white.png” content_max_width=”60%” button_one_text_tablet=”FAQ” button_one_text_phone=”FAQ” button_one_text_last_edited=”on|phone” logo_image_url_tablet=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/Regulatory-Affairs-icon_blue.png” logo_image_url_phone=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/Regulatory-Affairs-icon_blue.png” logo_image_url_last_edited=”on|desktop” content_max_width_tablet=”60%” content_max_width_phone=”100%” content_max_width_last_edited=”on|phone” disabled_on=”off|off|off” _builder_version=”4.21.0″ _dynamic_attributes=”button_one_url” _module_preset=”default” title_line_height=”1.2em” content_font_size=”16px” content_line_height=”1.8em” background_color=”#0084B5″ background_image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/RA-banner_1920x1080.jpg” background_blend=”multiply” custom_button_one=”on” button_one_bg_color=”#F9B13F” button_one_border_width=”1px” button_one_letter_spacing=”1px” button_one_custom_margin=”40px|30px|20px||false|false” button_one_custom_margin_tablet=”40px||0px||false|false” button_one_custom_margin_phone=”40px|0px|0px||false|false” button_one_custom_margin_last_edited=”on|tablet” button_one_custom_padding=”||||false|false” custom_button_two=”on” button_two_bg_color=”#F9B13F” button_two_border_width=”1px” button_two_letter_spacing=”1px” button_two_custom_margin=”40px|30px|20px||false|false” button_two_custom_margin_tablet=”40px|30px|20px||false|false” button_two_custom_margin_phone=”40px|0px|0px||false|false” button_two_custom_margin_last_edited=”on|phone” button_two_custom_padding=”||||false|false” hover_enabled=”0″ title_font_size_tablet=”” title_font_size_phone=”48px” title_font_size_last_edited=”on|phone” background_color_phone=”rgba(0,132,181,0.6)” background_last_edited=”on|phone” background_enable_color_phone=”on” background_image_tablet=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/11\/RA-banner_1920x1080.jpg” background_enable_image_tablet=”on” background_enable_image_phone=”off” global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n
Do you want to know more?<\/strong><\/p>\n Take a look through our frequently asked questions to see if you can find the answers you are looking for.<\/p>\n <\/p>\n Can’t find the answer here?<\/strong><\/p>\n Get in touch – we will gladly help address your questions and concerns.<\/p>\n [\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ next_background_color=”#ffffff” _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” custom_padding=”||130px|||” bottom_divider_style=”arrow” bottom_divider_height=”200px” bottom_divider_height_tablet=”120px” bottom_divider_height_phone=”120px” bottom_divider_height_last_edited=”on|phone” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22%93}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.16″ _module_preset=”default” header_3_text_align=”center” header_3_text_color=”#FFFFFF” header_4_text_color=”gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83″ text_orientation=”center” background_layout=”dark” global_colors_info=”{%22gcid-9b15d31e-2ee0-47f1-8284-e8f18d27ff83%22:%91%22header_4_text_color%22%93}”]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_5,1_5,1_5,1_5,1_5″ use_custom_gutter=”on” gutter_width=”2″ _builder_version=”4.16″ _module_preset=”default” background_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” custom_margin=”||30px||false|false” custom_padding=”||0px||false|false” sticky_position=”top” sticky_limit_bottom=”body” sticky_position_tablet=”none” sticky_position_phone=”none” sticky_position_last_edited=”on|tablet” global_colors_info=”{%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22background_color%22,%22background_color%22%93}” custom_margin__sticky=”-50px||||false|false” custom_margin__sticky_enabled=”on|desktop” transform_styles__sticky_enabled=”on|desktop” width__sticky_enabled=”on|sticky” max_height__sticky_enabled=”on|desktop” transform_scale__sticky=”50%|50%” transform_scale__sticky_enabled=”on|desktop” transform_translate__sticky_enabled=”on|desktop” transform_rotate__sticky_enabled=”on|desktop” transform_skew__sticky_enabled=”on|desktop” transform_origin__sticky_enabled=”on|desktop”][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Regulatory Affairs” url=”#faq-ra” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Regulatory-Affairs-icon-blue.png” image_icon_width=”70px” _builder_version=”4.16″ _module_preset=”default” image_icon_custom_margin=”||||false|false” image_icon_custom_padding=”||||false|false” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover_enabled=”on|hover” icon_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop” header_text_color__hover=”#F9B13F”][\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Quality assurance” url=”#faq-qa” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Regulatory-Affairs-icon-blue_1.png” alt=”RAQA – Quality Assurance” image_icon_width=”70px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Medical Devices” url=”#faq-md” use_icon=”on” font_icon=”||fa||900″ icon_color=”#FFFFFF” image_icon_width=”70px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Health & Welfare Technology” url=”#faq-hwt” use_icon=”on” font_icon=”||fa||900″ icon_color=”#FFFFFF” image_icon_width=”70px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Councils & Hospitals” url=”#faq-ch” use_icon=”on” font_icon=”||fa||900″ icon_color=”#FFFFFF” image_icon_width=”55px” _builder_version=”4.16″ _module_preset=”default” text_orientation=”center” background_layout=”dark” global_colors_info=”{}” icon_color__hover=”#F9B13F” icon_color__hover_enabled=”on|hover” header_text_color__hover=”#F9B13F” header_text_color__hover_enabled=”on|desktop”][\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”faq-ra” module_id=”faq-ra” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||4px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Regulatory Affairs” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2023\/01\/Regulatory-Affairs-icon-blue.png” alt=”Mentoring” icon_placement=”left” content_max_width=”950px” content_max_width_tablet=”530px” content_max_width_phone=”280px” content_max_width_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”FAQ-RA” _builder_version=”4.14.8″ _module_preset=”default” global_module=”241″ saved_tabs=”all” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_accordion open_toggle_text_color=”gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f” open_toggle_background_color=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” closed_toggle_text_color=”gcid-55beddab-172e-48fd-9da1-bb715d655a4d” closed_toggle_background_color=”gcid-88bd245e-faae-493b-9828-50690d0703ad” icon_color=”gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1″ use_icon_font_size=”on” icon_font_size=”22px” _builder_version=”4.16″ _module_preset=”default” body_ul_item_indent=”40px” border_color_all=”gcid-88bd245e-faae-493b-9828-50690d0703ad” global_colors_info=”{%22gcid-88bd245e-faae-493b-9828-50690d0703ad%22:%91%22closed_toggle_background_color%22,%22border_color_all%22%93,%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22open_toggle_background_color%22,%22closed_toggle_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22icon_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22open_toggle_text_color%22%93}”][et_pb_accordion_item title=”What is Regulatory Affairs? ” open=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Regulatory Affairs<\/strong> is a profession within regulated industries, such as medical devices, pharmaceuticals or the financial sector.<\/p>\n Regulatory Affairs Professionals in the medical device industry are often responsible for:<\/p>\n <\/span>Due to the sheer demand for Regulatory Affairs Professionals, it is common that some or all of these tasks are outsourced.<\/span>\u00a0<\/span><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”What purpose do Medical Device Regulations (MDR) serve? ” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n Medical Device Regulations are always concerned with patient safety<\/strong>. This includes risk assesments and traceability, among other factors.<\/p>\n The Medical Device Regulation in the EU (2017\/745) states that it:<\/p>\n “\u2026.aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other.”<\/em><\/p>\n This means that each company must ensure that the risks associated with its products are minimized. In addition, the clinical benefits of the products must be demonstrated and documented.<\/p>\n Technical documentation must be contained in the company’s Quality Management System (QMS).<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”What are medical device %22product risk categories%22?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n Medical devices are classified based on their risk to users. These categories are, from the lowest risk groups to the highest: Class I, Is, Ir, Im, Is, IIa, IIb, and III.<\/p>\n The intended use of your product and it potential risk to users determine into which category it falls. By looking at similar devices on the market and comparing your product to them can give you a good idea of the risk category for your product. Custom-made or altered devices can fall into any risk category.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Where can I learn more about MDR?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n There are plenty of free webinars and sites where you can learn about Medical Device Regulations on the whole, or dive into specific topics, such as clinical evaluations.<\/p>\n Try Easy Medical Device’s free mini course: Or visit their extensive library of podcast interviews with subject matter experts on a wide range of topics: Greenlight Guru also offers many useful resources: You can find a wide range of well priced digital courses \u2013 just search online.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Are there any good webinars about MDR?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n There are some useful webinars created by Quality and Regulatory Professionals. They often help \u2018set-the-scene\u2019, teaching you the terms and purpose of\u00a0 certain tasks.<\/p>\n We recommend that you watch:<\/p>\n Greenlight Guru<\/strong> [\/et_pb_accordion_item][et_pb_accordion_item title=”Are there guidance documents available for European MDR?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n EU Guidance documents<\/strong><\/p>\n There are plenty of guidance documents that can help you understand what is required for medical device regulation.\u00a0 The EU\u2019s Medical Device Coordination Group (MDCG) and the European Association of Medical Devices Notified Bodies Team (NB) both included endorsed guides and documents on a range of topics:<\/p>\n MDCG<\/strong> Team-NB<\/strong> [\/et_pb_accordion_item][et_pb_accordion_item title=”Are medical device regulations different around the world?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n The short answer is “yes”. The requirements, prices and timelines can vary for each product risk category in each certifying authority.<\/p>\n But don’t be discouraged – we can help you make an overview and gather the required information.<\/p>\n Normally this regulation planning should be a part of your design and development process, but it is often first considered much later in the process.<\/p>\n Have a look at the list of the regulations in the primary markets here: [\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”faq-qa” module_id=”faq-qa” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||4px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Quality Assurance” image=”https:\/\/raqa.dk\/wp-content\/uploads\/2022\/12\/Regulatory-Affairs-icon-blue_1.png” alt=”RAQA – Quality Assurance” icon_placement=”left” content_max_width=”950px” content_max_width_tablet=”530px” content_max_width_phone=”280px” content_max_width_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”FAQ-QA” _builder_version=”4.14.8″ _module_preset=”default” global_module=”624″ saved_tabs=”all” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_accordion open_toggle_text_color=”#0084b5″ open_toggle_background_color=”#ffffff” closed_toggle_text_color=”#ffffff” closed_toggle_background_color=”#05ab9e” icon_color=”#93cfc8″ use_icon_font_size=”on” icon_font_size=”22px” _builder_version=”4.16″ _module_preset=”default” body_ul_item_indent=”40px” border_color_all=”#05ab9e” global_colors_info=”{%22gcid-88bd245e-faae-493b-9828-50690d0703ad%22:%91%22closed_toggle_background_color%22,%22border_color_all%22%93,%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22open_toggle_background_color%22,%22closed_toggle_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22icon_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22open_toggle_text_color%22%93}”][et_pb_accordion_item title=”What is a Quality Management System?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”on”]<\/p>\n A Quality Management System (QMS) is essentially a library of the company’s policies, processes, procedures, forms, and instructions that is carefully maintained to assist the company in managing quality.<\/span><\/p>\n The overall aim of a quality management system is to assist businesses in improving processes to <\/span>ensure product or service quality and consistently meet regulatory and customer requirements.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”What does a Quality Assurance Professional do?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n A Quality Assurance Professional or Quality Assurance Manager works within regulated industries, such as medical devices, pharmaceuticals, construction, financial, amongst others.<\/p>\n Their primary goal is to guarantee product or service quality.<\/p>\n In the medical device industry, QA Professionals are often responsible for:<\/p>\n In small companies, i<\/span>t is common that some or all of these tasks are outsourced.<\/span>\u00a0<\/span><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Which are the main standards that are relevant for QA?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n The main standards that are relevant for most medical device companies are ISO 13485, ISO 14791, ISO 15223-1, and IEC 62366.<\/p>\n For other product specific standards and national or regional specific standards, we recommend you search the internet for information, or contact RAQA for a consultation. With our many years of experience, we can help you determine which standards are relevant for your product in each of your desired markets.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Which online Quality Management Systems do we recommend?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n There are many good online QMS systems. Recently, we have worked with:<\/p>\n There are also well known ones like:<\/p>\n In addition, some companies use programs such as:<\/p>\n In general, most of these are good systems, though we tend to recommend programs that are designed specifically as Quality Management Systems.\u00a0 Many software companies choose to build their own system, which can also be a good solution. Regardless of the solution you choose, we can help you optimize your system and populate it with the necessary documents. If you need help figuring out which system to use, let us have a chat about your products and desired markets. We can recommend a QMS that will best fit your needs.<\/p>\n Regardless of what you choose, we highly recommend that you ask for a demonstration of any system you are considering adopting. In addition, ask for additional discounts or features, like one month’s free trial.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Which processes need to be documented in a QMS?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n All processes, from the products conceptualization to its removal from the market, need to be documented and saved in the QMS.<\/p>\n Here are some useful guides focusing on the use of QMS in medical device companies: https:\/\/www.greenlight.guru\/blog\/iso-13485-qms-medical-device<\/a><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Who can do Internal and Supplier Audits?” open=”off” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Typically, an employee or external contractor who has taken a course in auditing process and methods can perform internal or suppliers audits. The advantage of having an external contractor conduct audits is that they have no previous contact with the department or supplier and consider things from an objective point-of-view. Additionally, they can shed light on issues with existing processes and conflicting opinions.<\/p>\n Easy Medical Device has a useful blog post about internal audits: https:\/\/easymedicaldevice.com\/internal-audit\/<\/a><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Are medical device QMS requirements different around the world?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n The short answer is “yes”. The requirements vary, especially with regards to reporting and language requirements. They may appear to be similar, but they often have a different approach or different required details.<\/p>\n RAQA can help you identify these differences and implement the necessary adjustments in your practices.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Why do I need a Quality Agreement with a supplier?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n You need a Quality Agreement with suppliers to establish ground rules which reflect the requirements of the industry and business that you are in. The agreement can be simple and focus only on Medical Device Regulation requirements, product specifications and non-conformities, or can be much more detailed.<\/p>\n RAQA recommends that the Quality Agreement is always a separate document than the financial agreement, as they serve different functions.<\/p>\n [\/et_pb_accordion_item][\/et_pb_accordion][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”faq-md” module_id=”faq-md” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”||4px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Medical Devices” use_icon=”on” font_icon=”||fa||900″ icon_placement=”left” image_icon_width=”96px” content_max_width=”950px” content_max_width_tablet=”530px” content_max_width_phone=”280px” content_max_width_last_edited=”on|phone” _builder_version=”4.16″ _module_preset=”default” header_level=”h2″ image_icon_custom_margin=”-10px|||-30px|false|false” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”||||false|false” global_colors_info=”{}”][\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”FAQ – Medical Devices” _builder_version=”4.14.8″ _module_preset=”default” global_module=”745″ global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_accordion open_toggle_text_color=”#0084b5″ open_toggle_background_color=”#ffffff” closed_toggle_text_color=”#ffffff” closed_toggle_background_color=”#05ab9e” icon_color=”#93cfc8″ use_icon_font_size=”on” icon_font_size=”22px” admin_label=”faq-md” _builder_version=”4.16″ _module_preset=”default” body_ul_item_indent=”40px” border_color_all=”#05ab9e” global_colors_info=”{%22gcid-88bd245e-faae-493b-9828-50690d0703ad%22:%91%22closed_toggle_background_color%22,%22border_color_all%22%93,%22gcid-55beddab-172e-48fd-9da1-bb715d655a4d%22:%91%22open_toggle_background_color%22,%22closed_toggle_text_color%22%93,%22gcid-d16d7f18-d8a1-4780-9f36-96f9fadec8b1%22:%91%22icon_color%22%93,%22gcid-784f0875-0bfd-4b88-9c25-ae287f4a1f5f%22:%91%22open_toggle_text_color%22%93}”][et_pb_accordion_item title=”What are Medical Devices?” open=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n Medical devices <\/strong>are products used for health reasons. The common theme is that they all serve a therapeutic purpose. Examples range from everyday items like band-aids and syringes to daily living aids like wheelchairs and products like implants and MRI scanners. They can even encompass periphery products like health-based apps, software and medical journaling systems.<\/p>\n <\/span><\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”What purpose do Medical Device Regulations (MDR) serve? ” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n The purpose of Medical Device reglations is always a question of of patient safety<\/strong>. This includes risk assesments and traceability, among other factors.<\/p>\n The Medical Device Regulations in the EU (2017\/745) states that it:<\/p>\n “\u2026.aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other.”<\/em><\/p>\n This means that the company must ensure that the risks associated with their products are minimized. In addition, the clinical benefits of the products must be demonstrated and documented. Technical documentation must be contained in a Quality Management System (QMS) within the company.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Where can I learn more about MDR?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n There are plenty of great free webinars and sites where you can learn about Medical Device Regulations as a whole, or dive into specific topics, such as clinical evaluations.<\/p>\n Try Easy Device Devices free mini course: They also have a great library of expert interviews podcasts on a wide range of topics: Greenlight Guru also has plenty of inspiring materials: There is also a huge range of well priced digital courses \u2013 just search online.<\/p>\n [\/et_pb_accordion_item][et_pb_accordion_item title=”Are there any good webinars about MDR?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n There are some useful webinars created by Quality and Regulatory Professionals. They often help \u2018set-the-scene\u2019, teaching you the terms and purpose of\u00a0 certain tasks.<\/p>\n We recommend that you watch:<\/p>\n Greenlight Guru<\/strong> [\/et_pb_accordion_item][et_pb_accordion_item title=”Are there guidance documents available for European MDR?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n EU Guidance documents<\/strong><\/p>\n There are plenty of guidance documents that can show you and help you understand what is required for medical device regulation.\u00a0 The EU\u2019s Medical Device Coordination Group (MDCG) and the European Association of Medical Devices Notified Bodies Team (NB) both included endorsed guides and documents on a range of topics:<\/p>\n MDCG<\/strong> Team-NB<\/strong> [\/et_pb_accordion_item][et_pb_accordion_item title=”Are medical device regulations different around the world?” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}” open=”off”]<\/p>\n The short answer is “yes”. The requirements, prices and timelines can vary for each product risk category in each certifying authority.<\/p>\n But don’t be discouraged – we can help you make an overview and gather the required information.<\/p>\n Normally this regulation planning should be a part of your design and development process, but it is often first considered much later in the process.<\/p>\nJump to a topic<\/h2>\n
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https:\/\/easymedicaldevice.com\/resource\/resource-medical-device-regulation\/mini-course-mdr\/<\/a><\/p>\n
https:\/\/podcast.easymedicaldevice.com\/<\/a>
Or on YouTube:
https:\/\/www.youtube.com\/c\/EasyMedicalDevice<\/a><\/p>\n
https:\/\/www.greenlight.guru\/medical-device-resources\/ebooks-and-guides<\/a><\/p>\n
https:\/\/www.greenlight.guru\/medical-device-resources\/webinars<\/a><\/p>\n
https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a><\/p>\n
https:\/\/www.team-nb.org\/team-nb-documents\/<\/a><\/p>\n
https:\/\/easymedicaldevice.com\/resource\/resource-medical-device-regulation\/<\/a><\/p>\n\n
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https:\/\/easymedicaldevice.com\/resource\/resource-medical-device-regulation\/mini-course-mdr\/<\/a><\/p>\n
https:\/\/podcast.easymedicaldevice.com\/<\/a> Or on YouTube:
https:\/\/www.youtube.com\/c\/EasyMedicalDevice<\/a><\/p>\n
https:\/\/www.greenlight.guru\/medical-device-resources\/ebooks-and-guides<\/a><\/p>\n
https:\/\/www.greenlight.guru\/medical-device-resources\/webinars<\/a><\/p>\n
https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en<\/a><\/p>\n
https:\/\/www.team-nb.org\/team-nb-documents\/<\/a><\/p>\n