{"id":3655,"date":"2026-02-25T10:42:36","date_gmt":"2026-02-25T09:42:36","guid":{"rendered":"https:\/\/www.inmedis.ch\/dienstleistungen\/managementsystem-medizintechnik\/"},"modified":"2026-05-20T16:39:50","modified_gmt":"2026-05-20T14:39:50","slug":"management-systems-and-organisational-development-in-the-medical-technology-sector","status":"publish","type":"page","link":"https:\/\/www.inmedis.ch\/en\/services\/management-systems-and-organisational-development-in-the-medical-technology-sector\/","title":{"rendered":"Management systems and organisational development in the medical technology sector"},"content":{"rendered":"<h1>Management systems and organisational development in MedTech: designing effective structures and processes<\/h1>\n<div>\n<p>Organisational development in medical technology connects regulatory requirements with the practical functioning of a company, embedded within a management system.<\/p>\n<p>The objective is to align structures and processes in a way that they work in day-to-day operations while meeting the requirements of the medical device industry.<\/p>\n<\/div>\n<hr>\n<div>Your contacts<\/div>\n<ul>\n<li>\n<\/li>\n<li>\n<\/li>\n<\/ul>\n<hr>\n<div>\n<p>Companies in the medical technology sector operate in an environment characterised by high regulatory requirements and complex processes. For a management system to be effective, it is not sufficient to formally document requirements. What matters is that organisational structures, responsibilities, and processes are designed so that they are applied in daily operations and remain transparent.<\/p>\n<p>Organisational development and work on the management system are therefore closely interlinked. An effective system only emerges when structures, processes, people, and infrastructure \u2013 including IT \u2013 are aligned with one another.<\/p>\n<\/div>\n<h2>What is meant by quality management in MedTech<\/h2>\n<div>\n<p>A management system describes the entirety of structures, processes, and rules by which a company is managed. In MedTech, this notably includes quality management systems that reflect regulatory and normative requirements.<\/p>\n<p>Organisational development complements this system with a business-oriented perspective aimed at the continuous development of organisational structures and processes. This includes, for example, questions of responsibilities, process design, and collaboration within the company, ensuring that the organisation remains agile, efficient, and effective.<\/p>\n<p>Together, this results in an integrated approach. Requirements arising from standards and regulations are not implemented in isolation but are viewed from a business perspective and aligned with the company\u2019s strategic direction.<\/p>\n<\/div>\n<h2>Typical challenges in organisational development in MedTech<\/h2>\n<div>\n<p>Many companies face the challenge of integrating regulatory requirements into existing organisational structures. In many cases, processes have evolved over time and are not consistently aligned.<\/p>\n<p>Unclear responsibilities, a lack of transparency in processes, and inconsistent ways of working often result in management systems being poorly accepted by employees and only partially implemented in day-to-day operations. At the same time, pressure is increasing due to audits, certifications, regulatory requirements, and customer expectations.<\/p>\n<p>Change itself also represents a key challenge. New regulatory requirements, organisational growth, market developments, and strategic realignments require adjustments that must be implemented both structurally and culturally.<\/p>\n<\/div>\n<h2>Our objectives are<\/h2>\n<div>\n<p>We establish a clear and transparent organisational structure in which tasks, roles, and responsibilities are clearly defined.<\/p>\n<p>Another objective is to design processes in a way that makes them simple, efficient, transparent, and applicable in day-to-day operations. Management systems should not be perceived as an additional burden but should serve as an integral part of business management.<\/p>\n<p>In addition, we support companies in systematically integrating regulatory requirements into their organisation. This creates structures that are sustainable in the long term and can be continuously developed.<\/p>\n<\/div>\n<h2>We work with<\/h2>\n<div>\n<p>Our services are aimed at companies in the medical technology sector as well as organisations in the healthcare industry that are looking to further develop or realign their structures and processes.<\/p>\n<p>Typical stakeholders include individuals in executive management, quality management, organisational development, and regulatory functions.<\/p>\n<p>Our collaboration is suitable both for companies in the start-up or growth phase and for organisations with established management systems that require adaptation or expansion.<\/p>\n<\/div>\n<h2>Our services include<\/h2>\n<div>\n<h4>Analysis and understanding of the current situation<\/h4>\n<ul>\n<li>Conducting employee and customer surveys as well as interviews<\/li>\n<li>Assessing the current organisational setup (Current Mode of Operation)<\/li>\n<li>Performing risk assessments related to the organisation and its processes<\/li>\n<\/ul>\n<h4>Strategic alignment and target operating model<\/h4>\n<ul>\n<li>Developing the overall business strategy<\/li>\n<li>Defining strategic initiatives and supporting their implementation<\/li>\n<li>Advising on organisational development planning (Future Mode of Operation)<\/li>\n<\/ul>\n<h4>Design of structures, processes, and systems<\/h4>\n<ul>\n<li>Designing organisational structures<\/li>\n<li>Developing company processes<\/li>\n<li>Conceptualising and documenting the management system<\/li>\n<\/ul>\n<h4>Setting-up management and control instruments<\/h4>\n<ul>\n<li>Implementing a Management Information System (MIS)<\/li>\n<\/ul>\n<h4>\u00a0Implementation and operationalisation<\/h4>\n<ul>\n<li>Training employees<\/li>\n<li>Actively supporting the implementation of new or adapted structures, processes, and corporate culture<\/li>\n<li>Supporting managers and employees throughout the transition<\/li>\n<\/ul>\n<h4>Operation, monitoring, and continuous improvement<\/h4>\n<ul>\n<li>Conducting internal audits<\/li>\n<li>Supporting certification body audits and customer audits<\/li>\n<li>Assisting in quality data analysis, reporting, and management review<\/li>\n<li>Optimising and further developing corporate culture, organisational structures, processes, and management systems<\/li>\n<\/ul>\n<h4>Strategic anchoring at top management level<\/h4>\n<ul>\n<li>Contributing expertise as a member of the Board of Directors or advisory board<\/li>\n<li>Supporting the organisation of the Board of Directors, advisory board, and corporate governance structures<\/li>\n<li>Defining interfaces between governance bodies and the organisation \/ management system<\/li>\n<\/ul>\n<p>Within our organisational work, we implement the following legal and regulatory requirements applicable to MedTech:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.iso.org\/standard\/62085.html\" target=\"_blank\" rel=\"noopener\">ISO 9001 Quality Management Systems \u2013 Requirements<\/a><\/li>\n<li><a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485 Medical Devices \u2013 Quality Management Systems for regulatory purposes<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/quality-management-system-regulation-qmsr\" target=\"_blank\" rel=\"noopener\">FDA 21 CFR Part 820 Quality Management System Regulation (QMSR)<\/a><\/li>\n<li><a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/de?version=20260630\" target=\"_blank\" rel=\"noopener\">Swiss Medical Devices Ordinance MepV 812.213<\/a><\/li>\n<li><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/ALL\/?uri=CELEX:32017R0745\" target=\"_blank\" rel=\"noopener\"><\/a><a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2017\/745 on medical devices (MDR)<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/medical-devices\/cdrh-international-affairs\/medical-device-single-audit-program-mdsap\" target=\"_blank\" rel=\"noopener\">Medical Device Single Audit Program MDSAP<\/a><\/li>\n<\/ul>\n<\/div>\n<h3>Further services<\/h3>\n<div>\n<p>    <img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/02\/link-icon_pfeil.svg\" alt=\"\"><\/p>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/02\/link-icon_pfeil-weiss.svg\" alt><\/p>\n<\/div>\n<h2>\n<div>Our collaboration<\/div>\n<\/h2>\n<div>\n<p>Our collaboration is based on clearly defined tasks and aligned project structures. In doing so, we build on the existing processes and ways of working within the organisation.<\/p>\n<p>Analyses, assessments, and recommendations are documented in a transparent and traceable manner, enabling their use in further development and quality-related activities.<\/p>\n<p>Collaboration can be structured on a project basis or integrated into ongoing development and quality processes in the long term.<\/p>\n<\/div>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/05\/christian-imfeld_quote-1.png\" alt=\"\"><br \/>\n<img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/05\/christian-imfeld_quote-1.png\" alt=\"\"><\/p>\n<h2>Next step<\/h2>\n<div>\n<p>We are pleased to assess your current situation regarding management systems and organisational development and jointly define the most suitable support approach.<\/p>\n<\/div>\n<p><p>\n        <a href=\"https:\/\/www.inmedis.ch\/en\/contact\/\">Get in touch<\/a>\n    <\/p>\n<\/p>\n<p><!--more--><br \/>\n<!-- {\"type\":\"layout\",\"children\":[{\"type\":\"section\",\"props\":{\"animation\":\"slide-top-medium\",\"animation_delay\":\"60\",\"css\":\".el-section {\\n\\tpadding-top:50px;\\n}\",\"image\":\"wp-content\/uploads\/2026\/02\/inmedis_pattern-solid-v02.svg\",\"image_position\":\"center-center\",\"image_width\":1800,\"media_overlay\":\"rgba(247, 248, 252, 0.19)\",\"media_visibility\":\"s\",\"padding_top\":\"large\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"large\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"4-5\"},\"children\":[{\"type\":\"headline\",\"props\":{\"block_align_fallback\":\"center\",\"content\":\"Management systems and organisational development in MedTech: designing effective structures and processes\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"margin\":\"small\",\"text_align\":\"left\",\"text_align_fallback\":\"center\",\"title_element\":\"h1\",\"title_style\":\"heading-small\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>Organisational development in medical technology connects regulatory requirements with the practical functioning of a company, embedded within a management system.<\/p>\n\n\\n\n\n<p>The objective is to align structures and processes in a way that they work in day-to-day operations while meeting the requirements of the medical device industry.<\/p>\n\n\",\"css\":\".el-element {\\n    font-family: Poppins;\\n}\",\"margin\":\"large\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_style\":\"lead\"}}]},{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"1-5\"}}],\"props\":{\"layout\":\"4-5,1-5\"}}],\"name\":\"Hero \u2013 Level 2 - Final\"},{\"type\":\"section\",\"props\":{\"animation\":\"slide-right-medium\",\"animation_delay\":\"60\",\"id\":\"kontakt\",\"image_position\":\"center-center\",\"padding_bottom\":\"small\",\"padding_remove_top\":true,\"padding_top\":\"small\",\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"large\"},\"children\":[{\"type\":\"row\",\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\"},\"children\":[{\"type\":\"divider\",\"props\":{\"divider_element\":\"hr\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Your contacts\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"div\",\"title_style\":\"h3\"}},{\"type\":\"grid\",\"props\":{\"content_column_breakpoint\":\"m\",\"content_margin\":\"remove\",\"css\":\".el-image {\\n    aspect-ratio: 1 \/ 1;\\n    object-fit: cover;\\n    object-position: top center;\\n    width: 100%;\\n    height: auto;\\n}\",\"filter_align\":\"left\",\"filter_all\":true,\"filter_grid_breakpoint\":\"m\",\"filter_grid_width\":\"auto\",\"filter_position\":\"top\",\"filter_style\":\"tab\",\"grid_default\":\"2\",\"grid_medium\":\"3\",\"icon_width\":80,\"image_align\":\"left\",\"image_grid_breakpoint\":\"m\",\"image_grid_width\":\"1-2\",\"image_link\":false,\"image_svg_color\":\"emphasis\",\"image_vertical_align\":true,\"item_animation\":true,\"lightbox_bg_close\":true,\"link_style\":\"text\",\"link_text\":\"\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"meta_align\":\"below-title\",\"meta_element\":\"div\",\"meta_style\":\"text-meta\",\"panel_link\":true,\"show_content\":true,\"show_hover_image\":true,\"show_hover_video\":true,\"show_image\":true,\"show_link\":true,\"show_meta\":true,\"show_title\":true,\"show_video\":true,\"title_align\":\"top\",\"title_color\":\"primary\",\"title_element\":\"h3\",\"title_grid_breakpoint\":\"m\",\"title_grid_width\":\"1-2\",\"title_hover_style\":\"reset\"},\"children\":[{\"type\":\"grid_item\",\"props\":{\"link_text\":\"About Claudio\",\"meta\":\"\"},\"source\":{\"query\":{\"name\":\"mitarbeiters.customMitarbeiter\",\"arguments\":{\"terms\":[],\"team_kategorien_operator\":\"IN\",\"users\":[],\"users_operator\":\"IN\",\"date_range\":\"relative\",\"date_relative\":\"next\",\"date_relative_unit\":\"day\",\"date_relative_unit_this\":\"day\",\"offset\":0,\"order\":\"date\",\"order_direction\":\"DESC\",\"id\":2817}},\"props\":{\"title\":{\"name\":\"title\"},\"content\":{\"name\":\"field.funktion_ausbildung\"},\"image\":{\"name\":\"featuredImage.url\"},\"image_alt\":{\"name\":\"featuredImage.alt\"},\"link\":{\"name\":\"link\"}}}},{\"type\":\"grid_item\",\"props\":{\"link_text\":\"About Christian\",\"meta\":\"\"},\"source\":{\"query\":{\"name\":\"mitarbeiters.customMitarbeiter\",\"arguments\":{\"terms\":[],\"team_kategorien_operator\":\"IN\",\"users\":[],\"users_operator\":\"IN\",\"date_range\":\"relative\",\"date_relative\":\"next\",\"date_relative_unit\":\"day\",\"date_relative_unit_this\":\"day\",\"offset\":0,\"order\":\"date\",\"order_direction\":\"DESC\",\"id\":3187}},\"props\":{\"title\":{\"name\":\"title\"},\"content\":{\"name\":\"field.funktion_ausbildung\"},\"image\":{\"name\":\"featuredImage.url\"},\"image_alt\":{\"name\":\"featuredImage.alt\"},\"link\":{\"name\":\"link\"}}}}],\"name\":\"Ansprechpersonen\"},{\"type\":\"divider\",\"props\":{\"divider_element\":\"hr\",\"margin\":\"medium\",\"margin_top\":\"medium\"}}]}]}],\"name\":\"Ansprechpersonen \u2013 Leistungen\"},{\"type\":\"section\",\"props\":{\"animation\":\"slide-right-medium\",\"animation_delay\":\"60\",\"image_position\":\"center-center\",\"padding\":\"large\",\"padding_remove_top\":true,\"style\":\"default\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"middle\",\"width\":\"large\"},\"children\":[{\"type\":\"row\",\"props\":{\"column_gap\":\"large\",\"layout\":\"2-3,1-3\"},\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"2-3\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>Companies in the medical technology sector operate in an environment characterised by high regulatory requirements and complex processes. For a management system to be effective, it is not sufficient to formally document requirements. What matters is that organisational structures, responsibilities, and processes are designed so that they are applied in daily operations and remain transparent.<\/p>\n\n\\n\n\n<p>Organisational development and work on the management system are therefore closely interlinked. An effective system only emerges when structures, processes, people, and infrastructure \u2013 including IT \u2013 are aligned with one another.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_style\":\"lead\"}},{\"type\":\"headline\",\"props\":{\"content\":\"What is meant by quality management in MedTech\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>A management system describes the entirety of structures, processes, and rules by which a company is managed. In MedTech, this notably includes quality management systems that reflect regulatory and normative requirements.<\/p>\n\n\\n\n\n<p>Organisational development complements this system with a business-oriented perspective aimed at the continuous development of organisational structures and processes. This includes, for example, questions of responsibilities, process design, and collaboration within the company, ensuring that the organisation remains agile, efficient, and effective.<\/p>\n\n\\n\n\n<p>Together, this results in an integrated approach. Requirements arising from standards and regulations are not implemented in isolation but are viewed from a business perspective and aligned with the company\u2019s strategic direction.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Typical challenges in organisational development in MedTech\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>Many companies face the challenge of integrating regulatory requirements into existing organisational structures. In many cases, processes have evolved over time and are not consistently aligned.<\/p>\n\n\\n\n\n<p>Unclear responsibilities, a lack of transparency in processes, and inconsistent ways of working often result in management systems being poorly accepted by employees and only partially implemented in day-to-day operations. At the same time, pressure is increasing due to audits, certifications, regulatory requirements, and customer expectations.<\/p>\n\n\\n\n\n<p>Change itself also represents a key challenge. New regulatory requirements, organisational growth, market developments, and strategic realignments require adjustments that must be implemented both structurally and culturally.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Our objectives are\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>We establish a clear and transparent organisational structure in which tasks, roles, and responsibilities are clearly defined.<\/p>\n\n\\n\n\n<p>Another objective is to design processes in a way that makes them simple, efficient, transparent, and applicable in day-to-day operations. Management systems should not be perceived as an additional burden but should serve as an integral part of business management.<\/p>\n\n\\n\n\n<p>In addition, we support companies in systematically integrating regulatory requirements into their organisation. This creates structures that are sustainable in the long term and can be continuously developed.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"headline\",\"props\":{\"content\":\"We work with\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>Our services are aimed at companies in the medical technology sector as well as organisations in the healthcare industry that are looking to further develop or realign their structures and processes.<\/p>\n\n\\n\n\n<p>Typical stakeholders include individuals in executive management, quality management, organisational development, and regulatory functions.<\/p>\n\n\\n\n\n<p>Our collaboration is suitable both for companies in the start-up or growth phase and for organisations with established management systems that require adaptation or expansion.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Our services include\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<h4>Analysis and understanding of the current situation<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Conducting employee and customer surveys as well as interviews<\/li>\n\n\\n\n\n<li>Assessing the current organisational setup (Current Mode of Operation)<\/li>\n\n\\n\n\n<li>Performing risk assessments related to the organisation and its processes<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Strategic alignment and target operating model<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Developing the overall business strategy<\/li>\n\n\\n\n\n<li>Defining strategic initiatives and supporting their implementation<\/li>\n\n\\n\n\n<li>Advising on organisational development planning (Future Mode of Operation)<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Design of structures, processes, and systems<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Designing organisational structures<\/li>\n\n\\n\n\n<li>Developing company processes<\/li>\n\n\\n\n\n<li>Conceptualising and documenting the management system<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Setting-up management and control instruments<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Implementing a Management Information System (MIS)<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>\u00a0Implementation and operationalisation<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Training employees<\/li>\n\n\\n\n\n<li>Actively supporting the implementation of new or adapted structures, processes, and corporate culture<\/li>\n\n\\n\n\n<li>Supporting managers and employees throughout the transition<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Operation, monitoring, and continuous improvement<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Conducting internal audits<\/li>\n\n\\n\n\n<li>Supporting certification body audits and customer audits<\/li>\n\n\\n\n\n<li>Assisting in quality data analysis, reporting, and management review<\/li>\n\n\\n\n\n<li>Optimising and further developing corporate culture, organisational structures, processes, and management systems<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Strategic anchoring at top management level<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Contributing expertise as a member of the Board of Directors or advisory board<\/li>\n\n\\n\n\n<li>Supporting the organisation of the Board of Directors, advisory board, and corporate governance structures<\/li>\n\n\\n\n\n<li>Defining interfaces between governance bodies and the organisation \/ management system<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<p>Within our organisational work, we implement the following legal and regulatory requirements applicable to MedTech:<\/p>\n\n\\n\n\n<ul>\\n\n\n<li><a href=\\\"https:\/\/www.iso.org\/standard\/62085.html\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">ISO 9001 Quality Management Systems \u2013 Requirements<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.iso.org\/standard\/59752.html\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">ISO 13485 Medical Devices \u2013 Quality Management Systems for regulatory purposes<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/quality-management-system-regulation-qmsr\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">FDA 21 CFR Part 820 Quality Management System Regulation (QMSR)<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/de?version=20260630\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">Swiss Medical Devices Ordinance MepV 812.213<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/ALL\/?uri=CELEX:32017R0745\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\"><\/a><a href=\\\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">Regulation (EU) 2017\/745 on medical devices (MDR)<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.fda.gov\/medical-devices\/cdrh-international-affairs\/medical-device-single-audit-program-mdsap\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">Medical Device Single Audit Program MDSAP<\/a><\/li>\n\n\\n<\/ul>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}}]},{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky\":\"column\",\"position_sticky_breakpoint\":\"m\",\"position_sticky_offset\":\"115\",\"width_medium\":\"1-3\"},\"children\":[{\"type\":\"headline\",\"props\":{\"content\":\"Further services\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h3\"}},{\"type\":\"grid\",\"props\":{\"attributes\":\"uk-height-match=\\\"target: .uk-grid .el-item > .uk-card\\\"\",\"content_column_breakpoint\":\"m\",\"css\":\".el-item > a > div {\\n    height: 100%;\\n}\\n\\n.uk-width-1-5.uk-flex-last .el-image {\\n    float: 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\u2013 Liste vertikal\"}]}]}],\"name\":\"Inhalt\"},{\"type\":\"section\",\"props\":{\"animation\":\"slide-right-medium\",\"animation_delay\":\"60\",\"header_transparent\":false,\"header_transparent_noplaceholder\":true,\"header_transparent_text_color\":\"dark\",\"height\":\"viewport\",\"height_offset_top\":true,\"height_viewport\":60,\"image_position\":\"center-center\",\"image_size\":\"cover\",\"media_overlay\":\"rgba(0, 45, 66, 0.69)\",\"padding\":\"large\",\"padding_remove_bottom\":false,\"style\":\"muted\",\"title_breakpoint\":\"xl\",\"title_position\":\"top-left\",\"title_rotation\":\"left\",\"vertical_align\":\"bottom\",\"width\":\"large\"},\"children\":[{\"type\":\"row\",\"props\":{\"layout\":\"2-5,3-5\"},\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"2-5\"},\"children\":[{\"type\":\"headline\",\"props\":{\"content\":\"\n\n<div>Our collaboration<\/div>\n\n\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\",\"title_style\":\"h1\"}}]},{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"width_medium\":\"3-5\"},\"children\":[{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>Our collaboration is based on clearly defined tasks and aligned project structures. In doing so, we build on the existing processes and ways of working within the organisation.<\/p>\n\n\\n\n\n<p>Analyses, assessments, and recommendations are documented in a transparent and traceable manner, enabling their use in further development and quality-related activities.<\/p>\n\n\\n\n\n<p>Collaboration can be structured on a project basis or integrated into ongoing development and quality processes in the long term.<\/p>\n\n\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_style\":\"lead\"}}]}]},{\"type\":\"row\",\"props\":{\"margin\":\"remove-vertical\"},\"children\":[{\"type\":\"column\",\"props\":{\"image_position\":\"center-center\",\"image_size\":\"width-1-1\",\"position_sticky_breakpoint\":\"m\",\"vertical_align\":\"bottom\",\"width_medium\":\"1-1\"},\"children\":[{\"type\":\"image\",\"props\":{\"css\":\".el-element {\\n\\tmargin-bottom:-13px !important;\\n}\",\"image\":\"wp-content\/uploads\/2026\/05\/christian-imfeld_quote-1.png\",\"image_svg_color\":\"emphasis\",\"image_width\":650,\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"position\":\"relative\",\"position_left\":\"0\",\"position_z_index\":\"1\",\"visibility\":\"hidden-m\"},\"name\":\"Bild \u2013 Mobile\"},{\"type\":\"image\",\"props\":{\"css\":\".el-element {\\n\\tmargin-bottom:-16px !important;\\n}\",\"image\":\"wp-content\/uploads\/2026\/05\/christian-imfeld_quote-1.png\",\"image_svg_color\":\"emphasis\",\"image_width\":750,\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"position\":\"relative\",\"position_left\":\"200\",\"position_z_index\":\"1\",\"visibility\":\"m\"},\"name\":\"Bild \u2013 Desktop\"}]}]},{\"type\":\"row\",\"props\":{\"css\":\".uk-card-primary {\\n    \\tborder-radius:5px;\\n\\t\\tpadding:60px 60px 50px 50px;\\n}\\n\\n@media (min-width: 960px) {\\n    .uk-card-primary {\\n    \\tborder-radius:5px;\\n\\t\\tpadding:100px 240px 100px 80px;\\n\\t}\\n}\\n\\n\",\"row_gap\":\"collapse\"},\"children\":[{\"type\":\"column\",\"props\":{\"css\":\".uk-card-primary {\\n\\tbox-shadow: rgba(17, 17, 26, 0.1) 0px 8px 24px, rgba(17, 17, 26, 0.1) 0px 16px 56px, rgba(17, 17, 26, 0.1) 0px 24px 80px;\\n}\",\"image_position\":\"center-center\",\"position_sticky_breakpoint\":\"m\",\"style\":\"card-primary\"},\"children\":[{\"type\":\"headline\",\"props\":{\"content\":\"Next step\",\"css\":\"@media (max-width: 640px) {\\n    .el-element {\\n        font-size: 25px;\\n    }\\n}\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\",\"title_style\":\"h1\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>We are pleased to assess your current situation regarding management systems and organisational development and jointly define the most suitable support approach.<\/p>\n\n\",\"css\":\"@media (max-width: 640px) {\\n    .el-element {\\n        font-size: 18px;\\n    }\\n}\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_style\":\"lead\"}},{\"type\":\"button\",\"props\":{\"grid_column_gap\":\"small\",\"grid_row_gap\":\"small\",\"margin_bottom\":\"default\",\"margin_top\":\"medium\"},\"children\":[{\"type\":\"button_item\",\"props\":{\"button_style\":\"default\",\"content\":\"Get in touch\",\"dialog_layout\":\"modal\",\"dialog_offcanvas_flip\":true,\"icon_align\":\"left\",\"link\":\"kontakt\/\"}}]}]}]}],\"name\":\"Mitarbeiter Zitat \u2013 Geri\"}],\"version\":\"5.0.32\"} --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Management systems and organisational development in MedTech: designing effective structures and processes Organisational development in medical technology connects regulatory requirements with the practical functioning of a company, embedded within a management system. The objective is to align structures and processes in a way that they work in day-to-day operations while meeting the requirements of the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3648,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3655","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3655","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/comments?post=3655"}],"version-history":[{"count":17,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3655\/revisions"}],"predecessor-version":[{"id":4075,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3655\/revisions\/4075"}],"up":[{"embeddable":true,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3648"}],"wp:attachment":[{"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/media?parent=3655"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}