{"id":28972,"date":"2026-09-24T07:27:51","date_gmt":"2026-09-24T07:27:51","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?page_id=28972"},"modified":"2026-09-24T07:42:15","modified_gmt":"2026-09-24T07:42:15","slug":"vendor-agency-certification-iso-13485","status":"publish","type":"page","link":"https:\/\/quickbirdmedical.com\/en\/vendor-agency-certification-iso-13485\/","title":{"rendered":"Does My Software Vendor Need ISO 13485 &#038; ISO 27001 Certification?"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; admin_label=&#8221;Interactive: widget&#8221; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;60px|0px|60px|0px|false|false&#8221; custom_padding_tablet=&#8221;40px|0px|40px|0px|false|false&#8221; custom_padding_phone=&#8221;30px|0px|30px|0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.21.0&#8243; width=&#8221;90%&#8221; max_width=&#8221;1200px&#8221; custom_padding=&#8221;15px|0px|15px|0px|false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_code _builder_version=&#8221;4.21.0&#8243; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<style>.qbm-artikel{max-width:760px;margin:0 auto;font-family:'Open Sans',Helvetica,Arial,Lucida,sans-serif;color:#333} .qbm-artikel .qbm-back{font-size:16px;color:#2EA3F2;display:inline-block;margin-bottom:16px} .qbm-artikel h1.qbm-titel{font-size:34px;font-weight:700;line-height:1.2;color:#1bb8ea;text-align:center;padding-bottom:10px;margin:0} .qbm-artikel .qbm-meta{display:flex;justify-content:space-between;align-items:center;gap:12px;margin:14px 0 12px;font-size:16px;line-height:16px} .qbm-artikel .qbm-meta>span:last-child{display:flex;align-items:center;gap:8px;white-space:nowrap} .qbm-artikel .qbm-meta a{display:flex;align-items:center;gap:8px;color:#1bb8ea;white-space:nowrap} .qbm-artikel .qbm-meta img{width:40px;height:42px} .qbm-artikel .qbm-header-img{display:block;width:100%;height:auto;margin:0 0 30px} .qbm-artikel p,.qbm-artikel li,.qbm-artikel td,.qbm-artikel th,.qbm-artikel blockquote{font-size:16px;line-height:1.49} .qbm-artikel .post-table-container td,.qbm-artikel .post-table-container th{padding:.857em .587em;line-height:1.49} .qbm-artikel h2{font-size:30px;font-weight:700;line-height:1.25;color:#1bb8ea;padding-bottom:10px;margin-top:20px} .qbm-artikel h3{font-size:26px;font-weight:700;line-height:1.25;padding-bottom:10px;margin-top:10px} .qbm-artikel h4{font-size:22px;font-weight:700} .qbm-artikel ul{padding:0 0 23px 1em;list-style-type:disc} .qbm-artikel ul ul{padding-bottom:0} .qbm-artikel blockquote{margin:20px 0;border-left:5px solid #2ea3f2;padding-left:20px} .qbm-artikel .qbm-back-unten{margin-top:30px} @media (max-width:980px){.qbm-artikel .qbm-meta img{display:none}} @media (max-width:767px){.qbm-artikel h1.qbm-titel{font-size:28px}.qbm-artikel h2{font-size:22px}.qbm-artikel h3{font-size:19px}.qbm-artikel h4{font-size:17px}.qbm-artikel .qbm-meta{font-size:15px}}<\/style>\n<div class=\"qbm-artikel\"> <a class=\"qbm-back\" href=\"https:\/\/quickbirdmedical.com\/en\/blog\/\">\u2190 to the overview of all articles<\/a> <\/p>\n<h1 class=\"qbm-titel\">Does My Software Vendor Need ISO 13485 &#038; ISO 27001 Certification?<\/h1>\n<div class=\"qbm-meta\"><span>September 23, 2026<\/span><span>Contact Person: <a href=\"https:\/\/quickbirdmedical.com\/en\/kontakt\/\"><img decoding=\"async\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2024\/04\/malte_hexagon_website.webp\" alt=\"Malte Bucksch\" width=\"40\" height=\"42\">Malte Bucksch<\/a><\/span><\/div>\n<p> <img decoding=\"async\" class=\"qbm-header-img\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/09\/software-vendor-iso-13485-27001-certification-header.webp\" alt=\"Scale with certification seal and question mark: Does my software vendor need ISO 13485 &#038; ISO 27001 certification?\" width=\"2000\" height=\"692\"> <pee>Successfully developing regulated medical software or an app (e.g. a <a href=\"https:\/\/quickbirdmedical.com\/en\/diga-definition-criteria-app\/\">digital health application under \u00a733a SGB V<\/a>) is a complex undertaking.<\/pee> <pee>In addition to the <strong>MDR, ISO 13485 and ISO 27001<\/strong>, there are numerous other standards and laws you have to comply with (e.g. <a href=\"https:\/\/quickbirdmedical.com\/en\/iec-62304-medical-device-software-app\/\">IEC 62304<\/a>, IEC 62366, IEC 82304, ISO 14971, <a href=\"https:\/\/quickbirdmedical.com\/en\/digav-digital-health-applications-ordinance\/\">DiGAV<\/a>, GDPR, \u2026)<\/pee> <pee>Many manufacturers therefore outsource product development to a software vendor with the relevant expertise in order to get to market quickly and safely.<\/pee>\n<blockquote><pee><strong>This raises a central question:<\/strong><\/pee> <pee>Should you choose a <strong>certified<\/strong> software vendor? (according to ISO 13485 and ISO 27001)<\/pee> <pee>\u2026 or can you also succeed with a <strong>non-certified<\/strong> software vendor?<\/pee><\/blockquote>\n<pee>The answer is not always clear-cut and depends on several factors. This guide is intended to help you make the decision.<\/pee>\n<blockquote><pee><strong>In short:<\/strong><\/pee> <pee>There is no legal requirement for the software vendor itself to be certified according to ISO 13485. However, the MDR obliges the manufacturer to maintain a quality management system (Article 10(9) MDR). This includes selecting, evaluating and monitoring its suppliers (ISO 13485, clause 7.4 Purchasing). A software vendor certified according to ISO 13485 and ISO 27001 already meets these requirements in a verifiable way. For a medical device under the MDR or a DiGA, it is therefore the safer choice. For software without a medical purpose, no certificate is needed.<\/pee><\/blockquote>\n<h2>Table of Contents<\/h2>\n<ul>\n<li><a href=\"#1\">1. Relevant Certificates for Software Vendors<\/a>\n<ul>\n<li><a href=\"#1-1\">1.1 ISO 13485 Certificate for Quality Management of Medical Devices<\/a><\/li>\n<li><a href=\"#1-2\">1.2 ISO 27001 Certificate for Information Security<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#2\">2. Non-Certified vs. Certified Software Vendor<\/a>\n<ul>\n<li><a href=\"#2-1\">2.1 When Does a Non-Certified Vendor Work?<\/a><\/li>\n<li><a href=\"#2-2\">2.2 When Should You Choose a Certified Vendor?<\/a><\/li>\n<li><a href=\"#2-3\">2.3 Conclusion: Certified vs. Non-Certified<\/a><\/li>\n<\/ul>\n<\/li>\n<li><a href=\"#3\">3. Risks: Certified Vendor vs. Non-Certified Vendor<\/a><\/li>\n<\/ul>\n<h2 id=\"1\">1. Relevant Certificates for Software Vendors<\/h2>\n<pee>In the context of digital health applications (DiGA), medical apps and <a href=\"https:\/\/quickbirdmedical.com\/en\/software-medical-device-development-approval\/\">Software as a Medical Device (SaMD)<\/a>, <strong>exactly two certificates are particularly relevant when choosing a vendor<\/strong>:<\/pee> <pee><a href=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/09\/grafik-iso-13485-iso-27001-zertifikate-software-dienstleister.webp\"><img decoding=\"async\" class=\"aligncenter wp-image-28891 size-full\" src=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/09\/grafik-iso-13485-iso-27001-zertifikate-software-dienstleister.webp\" alt=\"The relevant certificates for medical software: ISO 13485 and ISO 27001\" width=\"1280\" height=\"660\" srcset=\"https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/09\/grafik-iso-13485-iso-27001-zertifikate-software-dienstleister.webp 1280w, https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/09\/grafik-iso-13485-iso-27001-zertifikate-software-dienstleister-980x505.webp 980w, https:\/\/quickbirdmedical.com\/wp-content\/uploads\/2026\/09\/grafik-iso-13485-iso-27001-zertifikate-software-dienstleister-480x248.webp 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1280px, 100vw\" \/><\/a><\/pee> <pee style=\"text-align: center;\"><strong>Figure 1: The relevant certificates for developing medical software and apps: ISO 13485 (quality management system) and ISO 27001 (information security management system)<\/strong><\/pee>\n<h3 id=\"1-1\">1.1 ISO 13485 Certificate for Quality Management of Medical Devices<\/h3>\n<pee><a href=\"https:\/\/quickbirdmedical.com\/en\/iso-13485-requirements-content\/\">ISO 13485<\/a> is an internationally recognized standard that defines the <strong>requirements for a comprehensive quality management system<\/strong> for the design and manufacture of medical devices. It ensures that the vendor has implemented processes that guarantee the safety and effectiveness of the medical device software.<\/pee> <pee>An ISO 13485 certified software vendor not only brings the <strong>necessary expertise in medical device development<\/strong>, but has also established a <strong>regulatory-compliant quality management system<\/strong> for developing medical software.<\/pee> <pee>Notified bodies even require an ISO 13485 certificate for a successful medical device approval.<\/pee>\n<h3 id=\"1-2\">1.2 ISO 27001 Certificate for Information Security<\/h3>\n<pee>ISO 27001 is a global standard for information security management systems (ISMS).<\/pee> <pee>An ISO 27001 certified vendor demonstrates the ability to <strong>protect confidential data, including the sensitive health data<\/strong> processed in digital health applications and medical software. The certification means that the vendor <strong>has established a comprehensive information security management system<\/strong>. The certified company has thus demonstrably implemented suitable security controls and processes to minimize risks such as data loss, theft or alteration.<\/pee> <pee>DiGA manufacturers, for example, are obliged to be <a href=\"https:\/\/quickbirdmedical.com\/en\/diga-certificate-data-protection-data-security\/\">certified according to ISO 27001<\/a>. The obligation for information security management therefore also extends to critical suppliers.<\/pee>\n<blockquote><pee><strong>Note:<\/strong><\/pee> <pee>Did you know that a <strong>certified vendor is audited for several days every year?<\/strong><\/pee> <pee>An accredited auditor ensures that the company works in compliance with the standards. You can therefore rely on the competence of your vendor.<\/pee><\/blockquote>\n<h2 id=\"2\">2. Non-Certified vs. Certified Software Vendor<\/h2>\n<h3 id=\"2-1\">2.1 When Does a Non-Certified Vendor Work?<\/h3>\n<pee>If you are developing health software that is <strong>not<\/strong> intended to become a medical device under the MDR or a DiGA, a <strong>non-certified vendor can also be a good option<\/strong>.<\/pee> <pee>Health lifestyle software that has <a href=\"https:\/\/quickbirdmedical.com\/en\/medizinprodukt-app-software-mdr\/\">no medical purpose<\/a> is not regulated as a medical device by the MDR. A good example would be a classic fitness app.<\/pee> <pee>In this case, your software vendor does not need any knowledge of medical device development and therefore no certified quality management system according to ISO 13485 either.<\/pee>\n<blockquote><pee><strong>Note:<\/strong><\/pee> <pee>Your software product may process <strong>personal<\/strong> health data.<\/pee> <pee>In that case, expect <strong>increased data protection requirements<\/strong> under the General Data Protection Regulation (GDPR). Look for software vendors with an ISO 27001 certificate to reduce the risk of data security incidents.<\/pee><\/blockquote>\n<h3 id=\"2-2\">2.2 When Should You Choose a Certified Vendor?<\/h3>\n<pee>The situation is different if you want to develop software or an app that qualifies as a <strong>medical device under the MDR<\/strong>. <strong>This includes in particular <a href=\"https:\/\/quickbirdmedical.com\/en\/diga-medical-device-class-mdr\/\">digital health applications (DiGA)<\/a><\/strong>. Legal responsibility always remains with the manufacturer. The manufacturer must demonstrate that it has selected and monitors its suppliers, including the software vendor, according to its quality management system.<\/pee> <pee>The <strong>likelihood of successful market approval, product success and business success increases significantly<\/strong> if you work with a certified software vendor for medical device software and DiGA.<\/pee> <pee>The certification of the software vendor ensures that <strong>all regulatory requirements are met<\/strong> and significantly reduces the risk of compliance problems. For medical, regulated applications, a certified partner can make the decisive <strong>difference between the success and failure of the project<\/strong>.<\/pee> <pee>You can find detailed information on this in <a href=\"#3\">chapter 3 \u201cRisks: Certified vs. Non-Certified Vendor\u201d<\/a>.<\/pee>\n<h3 id=\"2-3\">2.3 Conclusion: Certified vs. Non-Certified<\/h3>\n<blockquote><pee><strong>Our recommendation:<\/strong><\/pee> <pee>Work with a certified vendor if you \u2026<\/pee>\n<ul>\n<li>\u2026 want to develop software or an app <strong>as a regulated medical device<\/strong>.<\/li>\n<li>\u2026 want to get into the <a href=\"https:\/\/quickbirdmedical.com\/en\/diga-approval\/\"><strong>DiGA directory<\/strong><\/a> quickly and safely.<\/li>\n<\/ul>\n<pee>Certified software vendors do not have to laboriously build up quality management and information security processes first, and they bring a lot of practical experience in medical device development.<\/pee><\/blockquote>\n<pee>If your software is <strong>not<\/strong> a medical device and <strong>not<\/strong> a DiGA, you can work with a <strong>non-certified vendor<\/strong> without any problems.<\/pee> <pee>If you want to develop a <strong>medical device or a DiGA<\/strong> with a <strong>non<\/strong>-certified vendor, keep the risks and problems below in mind with the highest priority (see chapter 3).<\/pee>\n<h2 id=\"3\">3. Risks: Certified Vendor vs. Non-Certified Vendor<\/h2>\n<pee>The following table provides an overview of the most important risks and problems that can arise from non-certified vendors.<\/pee> <pee>If you plan to implement medical software with a <strong>non<\/strong>-certified vendor, keep these risks in mind <strong>at all times<\/strong> during the project.<\/pee>\n<div class=\"post-table-container\" style=\"overflow-x: scroll; width: 100%;\">\n<table>\n<tbody>\n<tr>\n<th style=\"text-align: left;\">Aspect<\/th>\n<th style=\"text-align: left;\">Non-certified vendor: risks<\/th>\n<th style=\"text-align: left;\">Certified vendor (according to ISO 13485 &#038; 27001): benefits<\/th>\n<\/tr>\n<tr>\n<td colspan=\"3\"><strong>Risks for product, company and managing directors<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Medical device under the MDR: legal consequences<\/strong><\/td>\n<td>Risk of violations of medical device law (high financial damage, loss of reputation and criminal consequences for individuals)<\/td>\n<td>Protection of the company and the managing directors through proven regulatory compliance according to ISO 13485<\/td>\n<\/tr>\n<tr>\n<td><strong>Data protection &#038; data security: legal consequences<\/strong><\/td>\n<td>Risk of data protection violations involving health data (high financial damage, loss of reputation and criminal consequences for individuals)<\/td>\n<td>Guaranteed data security and data protection according to ISO 27001 and GDPR<\/td>\n<\/tr>\n<tr>\n<td><strong>Compliance &#038; project success<\/strong><\/td>\n<td>Risk that the product does not reach the market due to non-compliance or has to be withdrawn from the market later<\/td>\n<td>Certainty about compliance and a safe market launch of the product<\/td>\n<\/tr>\n<tr>\n<td><strong>Harm to health<\/strong><\/td>\n<td>Risk of harm to patients<\/td>\n<td>Maximum patient safety<\/td>\n<\/tr>\n<tr>\n<td><strong>Problems in company audits<\/strong><\/td>\n<td>Missing proof of the vendor&#8217;s competence in the BfArM application for the DiGA or towards the notified body under the MDR<\/td>\n<td>Smooth processing with proof of competence through ISO certificates<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><strong>Internal costs and need for specialists<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Costs and time<\/strong><\/td>\n<td>High internal costs and time spent on onboarding, training, monitoring and auditing the vendor team<\/td>\n<td>Efficient way of working without additional onboarding or auditing of the vendor team<\/td>\n<\/tr>\n<tr>\n<td><strong>Need for specialists<\/strong><\/td>\n<td>Need to build up internal specialists for quality management and data security<\/td>\n<td>Reliance on the vendor&#8217;s expertise without the need for internal specialists<\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><strong>Market entry and market success<\/strong><\/td>\n<\/tr>\n<tr>\n<td><strong>Cooperation opportunities<\/strong><\/td>\n<td>Low trust and therefore limited cooperation and funding opportunities, e.g. with health insurers or public funding<\/td>\n<td>High trust and therefore diverse cooperation opportunities and access to funding through a quality seal<\/td>\n<\/tr>\n<tr>\n<td><strong>Time of product market entry<\/strong><\/td>\n<td>Delayed market entry due to an untrained vendor team and lengthy iteration loops<\/td>\n<td>Fast market entry thanks to an experienced and trained vendor team<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n<p> <a class=\"qbm-back qbm-back-unten\" href=\"https:\/\/quickbirdmedical.com\/en\/blog\/\">\u2190 to the overview of all articles<\/a> <\/div>\n<p>[\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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_builder_version=&#8221;4.16&#8243; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;rgba(255,255,255,0) 0%|rgba(255,255,255,0.18) 100%&#8221; background_color_gradient_start=&#8221;rgba(255,255,255,0)&#8221; background_color_gradient_end=&#8221;rgba(255,255,255,0.18)&#8221; custom_padding=&#8221;5%|6%|10%|6%&#8221; custom_padding_tablet=&#8221;&#8221; custom_padding_phone=&#8221;&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221; padding_last_edited=&#8221;on|desktop&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_text admin_label=&#8221;Title&#8221; _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; link_font=&#8221;||||||||&#8221; ul_font=&#8221;||||||||&#8221; ol_font=&#8221;||||||||&#8221; quote_font=&#8221;||||||||&#8221; header_font=&#8221;||||||||&#8221; header_2_font=&#8221;||||||||&#8221; header_2_font_size=&#8221;40px&#8221; header_2_letter_spacing=&#8221;2px&#8221; header_2_line_height=&#8221;1.5em&#8221; header_3_font=&#8221;||||||||&#8221; header_4_font=&#8221;||||||||&#8221; header_5_font=&#8221;||||||||&#8221; header_6_font=&#8221;Lato|700|||||||&#8221; header_6_font_size=&#8221;18px&#8221; header_6_letter_spacing=&#8221;1px&#8221; header_6_line_height=&#8221;1.8em&#8221; text_orientation=&#8221;right&#8221; background_layout=&#8221;dark&#8221; max_width=&#8221;600px&#8221; module_alignment=&#8221;right&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;22px&#8221; header_2_font_size_last_edited=&#8221;on|phone&#8221; text_orientation_tablet=&#8221;left&#8221; text_orientation_phone=&#8221;left&#8221; text_orientation_last_edited=&#8221;on|tablet&#8221; inline_fonts=&#8221;overpass-extralight&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Are you planning to implement medical software or a DiGA?<\/h2>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;5%|6%|10%|6%&#8221; custom_padding_tablet=&#8221;||150px|&#8221; custom_padding_phone=&#8221;&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221; padding_tablet=&#8221;||150px|&#8221; padding_last_edited=&#8221;on|desktop&#8221; custom_padding__hover=&#8221;|||&#8221; padding_phone=&#8221;||150px|&#8221;][et_pb_text _builder_version=&#8221;4.21.0&#8243; text_font=&#8221;Lato||||||||&#8221; text_font_size=&#8221;18px&#8221; text_line_height=&#8221;1.8em&#8221; background_layout=&#8221;dark&#8221; max_width=&#8221;600px&#8221; animation_style=&#8221;slide&#8221; animation_direction=&#8221;bottom&#8221; animation_intensity_slide=&#8221;5%&#8221; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;&#8221; text_font_size_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Contact us for a free initial consultation. We will give you an estimate of the effort and timeframe required to implement your project. 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