{"id":4040,"date":"2025-11-14T09:53:45","date_gmt":"2025-11-14T09:53:45","guid":{"rendered":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/?page_id=4040"},"modified":"2026-01-29T13:45:57","modified_gmt":"2026-01-29T13:45:57","slug":"medical-device-compliance","status":"publish","type":"page","link":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/our-services\/medical-device-compliance\/","title":{"rendered":"Medical device compliance"},"content":{"rendered":"<p>[et_pb_section bb_built=&#8221;1&#8243; admin_label=&#8221;section&#8221; fullwidth=&#8221;on&#8221; next_background_color=&#8221;#000000&#8243; global_module=&#8221;322&#8243;][et_pb_fullwidth_menu global_parent=&#8221;322&#8243; _builder_version=&#8221;3.0.106&#8243; menu_id=&#8221;7&#8243; submenu_direction=&#8221;downwards&#8221; fullwidth_menu=&#8221;off&#8221; background_layout=&#8221;dark&#8221; module_class=&#8221;main-navigation&#8221; \/][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; prev_background_color=&#8221;#000000&#8243; next_background_color=&#8221;#000000&#8243;][et_pb_row][et_pb_column type=&#8221;4_4&#8243;][et_pb_text admin_label=&#8221;Breadcrumbs (do not remove)&#8221; background_layout=&#8221;light&#8221; text_orientation=&#8221;left&#8221; use_border_color=&#8221;off&#8221; border_color=&#8221;#ffffff&#8221; border_style=&#8221;solid&#8221; module_class=&#8221;breadcrumbs&#8221; custom_css_main_element=&#8221;border-bottom: 1px solid #ececed;&#8221; module_alignment=&#8221;left&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_size=&#8221;initial&#8221;]<\/p>\n<span><span><a href=\"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/\">Digital Health Software and Platforms<\/a><\/span><\/span>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Medical device regulation&#8221; use_border_color=&#8221;off&#8221; border_color=&#8221;#ffffff&#8221; border_style=&#8221;solid&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_size=&#8221;initial&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h1 style=\"font-weight: 400;color: #28a0d8\">Medical device compliance<\/h1>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Introduction&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h2 style=\"font-weight: 400;color: #28a0d8\">Supporting safe, compliant digital health research under UK MDR 2002.<\/h2>\n<p>[\/et_pb_text][et_pb_image _builder_version=&#8221;3.17.6&#8243; src=&#8221;https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-content\/uploads\/sites\/251\/2026\/01\/medical-device-graphic.png&#8221; \/][et_pb_text admin_label=&#8221;Summary&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<p>Developing digital tools that influence health or care pathways often brings them into the scope of the UK Medical Devices Regulations (MDR 2002). We help research teams navigate this landscape by providing practical support, clear guidance, and the technical documentation required for Software as a Medical Device (SaMD).<\/p>\n<p>Our team ensure regulatory compliance with standards such IEC 62304, ISO 14971, UKMDR requirements and MHRA guidelines. Whether a project is already classified or requires early-stage advice, we help determine the appropriate regulatory pathway and ensure all required evidence and controls are in place.<\/p>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Spacer&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<p>\n&nbsp;<\/p>\n<p>[\/et_pb_text][et_pb_divider _builder_version=&#8221;3.17.6&#8243; \/][et_pb_text admin_label=&#8221;What we do&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h5>What we do<\/h5>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row][et_pb_column type=&#8221;1_2&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul>\n<li style=\"margin-bottom: 10px\">Develop SaMD products that support diagnosis, monitoring, treatment, or clinical decision support<\/li>\n<li style=\"margin-bottom: 10px\">Ensure regulatory compliance with standards such IEC 62304, ISO 14971, UKMDR requirements and MHRA guidelines<\/li>\n<li>Manage our processes through a QMS aligned to ISO 13485<\/li>\n<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul>\n<li style=\"margin-bottom: 10px\">Integrate your clinical expertise to ensure that product requirements, safety profiles, and user workflows align with real-world healthcare needs<\/li>\n<li>Maintain quality and cybersecurity, embedding risk management, validation, and secure development practices throughout the product lifecycle<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row][et_pb_column type=&#8221;4_4&#8243;][et_pb_text admin_label=&#8221;Spacer&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<p>\n&nbsp;<\/p>\n<p>[\/et_pb_text][et_pb_divider _builder_version=&#8221;3.17.6&#8243; \/][\/et_pb_column][\/et_pb_row][et_pb_row][et_pb_column type=&#8221;4_4&#8243;][et_pb_text admin_label=&#8221;Our process&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h5>Our role in the SaMD compliance process<\/h5>\n<p>[\/et_pb_text][et_pb_image _builder_version=&#8221;3.17.6&#8243; src=&#8221;https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-content\/uploads\/sites\/251\/2026\/01\/medical-device-process.png&#8221; \/][et_pb_text admin_label=&#8221;Spacer&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<p>\n&nbsp;<\/p>\n<p>[\/et_pb_text][et_pb_divider _builder_version=&#8221;3.17.6&#8243; \/][et_pb_text admin_label=&#8221;Outcomes&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h5>Outcomes<\/h5>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row][et_pb_column type=&#8221;1_2&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul>\n<li style=\"margin-bottom: 10px\">Regulatory-ready SaMD products that meet international standards and can be cleared or approved for use in the UK<\/li>\n<li>Safe, effective, and clinically relevant software that improves patient outcomes and supports healthcare decision-making<\/li>\n<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul>\n<li style=\"margin-bottom: 10px\">Efficient and traceable development workflows that reduce risk, accelerate compliance, and support long-term scalability.<\/li>\n<li>High stakeholder confidence, built through transparent documentation, robust risk controls, and consistent quality management.<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row][et_pb_column type=&#8221;4_4&#8243;][et_pb_text admin_label=&#8221;Spacer&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<p>\n&nbsp;<\/p>\n<p>[\/et_pb_text][et_pb_divider _builder_version=&#8221;3.17.6&#8243; \/][et_pb_text admin_label=&#8221;In action&#8221; _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h5>In action<\/h5>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row][et_pb_column type=&#8221;1_2&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<p>\nThe <strong>REMORA<\/strong> study involved developing a digital symptom-tracking tool for people with rheumatoid arthritis. As REMORA fell within the scope of UK MDR 2002, our team led the full SaMD compliance process. This included producing DCB0129 documentation, managing risk assessments, completing DPIAs, and integrating regulatory requirements into the development workflow. Our involvement ensured the system was safe, robust, and suitable for clinical evaluation, enabling the study team to progress confidently through regulatory and governance approvals.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243;][et_pb_image _builder_version=&#8221;3.17.6&#8243; src=&#8221;https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-content\/uploads\/sites\/251\/2025\/09\/remora-thumb.jpg&#8221; \/][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; specialty=&#8221;off&#8221; prev_background_color=&#8221;#000000&#8243; next_background_color=&#8221;#1d1d1d&#8221;][et_pb_fullwidth_slider admin_label=&#8221;Call to action&#8221; _builder_version=&#8221;3.17.6&#8243; link_option_url=&#8221;https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/contact\/&#8221;][et_pb_slide _builder_version=&#8221;3.17.6&#8243; heading=&#8221;Ready to collaborate?&#8221; button_text=&#8221;Get in touch&#8221; button_link=&#8221;https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/contact\/&#8221; link_option_url=&#8221;https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/contact\/&#8221;]<\/p>\n<p>Whether you&#8217;re planning a grant, launching a new study, or just some need advice from digital health experts &#8211; we\u2019d love to hear from you.<\/p>\n<p>[\/et_pb_slide][\/et_pb_fullwidth_slider][\/et_pb_section][et_pb_section bb_built=&#8221;1&#8243; admin_label=&#8221;Connect Title&#8221; custom_padding=&#8221;0px||0px|&#8221; _builder_version=&#8221;3.0.90&#8243; background_color=&#8221;#1d1d1d&#8221; module_class=&#8221;footer-section&#8221; prev_background_color=&#8221;#ffffff&#8221; global_module=&#8221;380&#8243;][et_pb_row admin_label=&#8221;row&#8221; global_parent=&#8221;380&#8243; locked=&#8221;off&#8221; allow_player_pause=&#8221;off&#8221; parallax=&#8221;off&#8221; parallax_method=&#8221;on&#8221; parallax_1=&#8221;off&#8221; parallax_method_1=&#8221;off&#8221; parallax_2=&#8221;off&#8221; parallax_method_2=&#8221;off&#8221; parallax_3=&#8221;off&#8221; parallax_method_3=&#8221;off&#8221; make_fullwidth=&#8221;off&#8221; use_custom_width=&#8221;off&#8221; width_unit=&#8221;on&#8221; use_custom_gutter=&#8221;off&#8221; make_equal=&#8221;off&#8221; module_id=&#8221;footer-row&#8221; _builder_version=&#8221;3.0.89&#8243;][et_pb_column type=&#8221;1_3&#8243;][et_pb_text admin_label=&#8221;Contact Us Title&#8221; global_parent=&#8221;380&#8243; background_layout=&#8221;dark&#8221; text_text_color=&#8221;#ffffff&#8221; parent_locked=&#8221;off&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_size=&#8221;initial&#8221;]<\/p>\n<h4>Contact Us<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Contact Us&#8221; global_parent=&#8221;380&#8243; text_text_color=&#8221;#aaaaaa&#8221; parent_locked=&#8221;off&#8221; background_layout=&#8221;light&#8221; text_orientation=&#8221;left&#8221; use_border_color=&#8221;off&#8221; border_color=&#8221;#ffffff&#8221; border_style=&#8221;solid&#8221; module_class=&#8221;contact-us&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_size=&#8221;initial&#8221;]<\/p>\n<p>+44 (0) 161 306 6000<\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243;][et_pb_text admin_label=&#8221;Find Us Title&#8221; global_parent=&#8221;380&#8243; background_layout=&#8221;dark&#8221; text_text_color=&#8221;#ffffff&#8221; parent_locked=&#8221;off&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_size=&#8221;initial&#8221;]<\/p>\n<h4>Find Us<\/h4>\n<p>[\/et_pb_text][et_pb_text admin_label=&#8221;Address&#8221; global_parent=&#8221;380&#8243; background_layout=&#8221;dark&#8221; text_orientation=&#8221;left&#8221; use_border_color=&#8221;off&#8221; border_color=&#8221;#ffffff&#8221; border_style=&#8221;solid&#8221; module_id=&#8221;address&#8221; parent_locked=&#8221;off&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; background_size=&#8221;initial&#8221;]<\/p>\n<p><a href=\"http:\/\/www.manchester.ac.uk\/discover\/maps\/interactive-map\/\">The University of Manchester<br \/>Oxford Rd<br \/>Manchester<br \/>M13 9PL<br \/>UK<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243;][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><div class=\"et_pb_row et_pb_row_0 et_pb_row_empty\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div> <span><span><a href=\"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/\">Digital Health Software and Platforms<\/a><\/span><\/span> Medical device compliance Supporting safe, compliant digital health research under UK MDR 2002. Developing digital tools that influence health or care pathways often brings them into the scope of the UK Medical Devices Regulations (MDR 2002). We help research teams navigate this landscape by providing practical support, clear guidance, and the technical documentation [&hellip;]<\/p>\n","protected":false},"author":3523,"featured_media":0,"parent":3903,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_exactmetrics_skip_tracking":false,"footnotes":""},"class_list":["post-4040","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/pages\/4040","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/users\/3523"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/comments?post=4040"}],"version-history":[{"count":15,"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/pages\/4040\/revisions"}],"predecessor-version":[{"id":4532,"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/pages\/4040\/revisions\/4532"}],"up":[{"embeddable":true,"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/pages\/3903"}],"wp:attachment":[{"href":"https:\/\/sites.manchester.ac.uk\/digital-health-software-and-platforms\/wp-json\/wp\/v2\/media?parent=4040"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}