{"id":3650,"date":"2021-01-04T16:29:37","date_gmt":"2021-01-04T15:29:37","guid":{"rendered":"https:\/\/www.inmedis.ch\/dienstleistungen\/quality-engineering-medizintechnik\/"},"modified":"2026-05-20T16:37:07","modified_gmt":"2026-05-20T14:37:07","slug":"quality-engineering-in-medical-technology","status":"publish","type":"page","link":"https:\/\/www.inmedis.ch\/en\/services\/quality-engineering-in-medical-technology\/","title":{"rendered":"Quality Engineering in Medical Technology"},"content":{"rendered":"<h1>Quality Engineering in MedTech: Systematically integrating quality into development and production<\/h1>\n<div>\n<p>Quality engineering in medical technology establishes the methodological foundation for systematically implementing quality requirements across the entire lifecycle of a medical device &#8211; from development to end-of-life.<\/p>\n<\/div>\n<hr>\n<div>Your contacts<\/div>\n<ul>\n<li>\n<\/li>\n<li>\n<\/li>\n<li>\n<\/li>\n<\/ul>\n<hr>\n<div>\n<p>Medical devices are developed in an environment with stringent requirements for safety, functionality, and regulatory traceability. In addition to the technical performance of a product, the quality of the underlying development and manufacturing processes therefore plays a critical role.<\/p>\n<p>Quality engineering in medical technology provides the methods and structures needed to consistently address quality requirements throughout the product lifecycle.<\/p>\n<p>Early integration of quality-driven methods reduces uncertainties in the development process and facilitates the subsequent assessment of product and process quality. Without such a structured approach, projects often require additional testing, adjustments, or repeated development cycles.<\/p>\n<\/div>\n<h2>What is meant by Quality Engineering in MedTech<\/h2>\n<div>\n<p>The term Quality Engineering (QE) in MedTech describes the application of systematic methods for designing and evaluating product and process quality. At its core is the question of how technical solutions can be developed in a way that defined quality requirements are reliably and reproducibly met.<\/p>\n<p>In the field of medical technology, this includes, among others, structured development processes, risk analyses, qualifications, as well as the validation of manufacturing processes and the product itself. Quality methods are directly integrated into development and production activities.<\/p>\n<p>Quality Engineering links product development with the requirements of a quality management system. At the same time, it provides a foundation for the transparent and traceable implementation of regulatory requirements related to documentation, evidence, and risk assessment.<\/p>\n<\/div>\n<h2>Typical challenges in quality engineering in the MedTech<\/h2>\n<div>\n<div>The development of medical devices often takes place under significant pressure to innovate. At the same time, extensive requirements for documentation, risk management, and process evidence must be fulfilled. This combination leads to organisational and technical challenges in many projects.<\/div>\n<p>A key difficulty lies in aligning technical development decisions with the necessary quality and regulatory evidence. Changes to product design or manufacturing processes can require substantial updates to risk analyses, testing strategies, and documentation.<\/p>\n<p>As multiple disciplines are typically involved, an additional level of complexity arises. Without aligned methods and clearly defined processes, information gaps or inconsistent assessments of risks and requirements can occur.<\/p>\n<\/div>\n<h2>Our objectives are<\/h2>\n<div>\n<p>Our work is focused on supporting development projects through clearly structured quality methods.<\/p>\n<p>A key focus lies on linking requirements, risks, verification\/validation activities, and decisions in a transparent and traceable manner. This creates a robust foundation for development decisions and subsequent regulatory assessments.<\/p>\n<p>In addition, we support companies in integrating quality methods as simply as possible into their project workflows, enabling efficient application by all involved teams. As a result, quality activities become an integral part of the development process.<\/p>\n<\/div>\n<h2>We work with<\/h2>\n<div>\n<p>Our services are aimed at manufacturers of medical devices seeking to structure or further develop their development and manufacturing processes in a systematic manner.<\/p>\n<p>Typical points of contact include professionals responsible for development, quality management, or production, as well as members of executive management. We often work with interdisciplinary teams in which technical, regulatory, and organisational aspects are addressed jointly.<\/p>\n<p>Our services are suitable both for smaller organisations, including start-ups with limited Quality Engineering resources, and for companies with established quality systems that aim to further develop and optimise their processes.<\/p>\n<\/div>\n<h2>Our services include<\/h2>\n<div>\n<p>Our services focus on the structured and practical application of quality methods in development and manufacturing projects.<\/p>\n<p>We support companies both in the methodological planning of quality activities and in their practical implementation within ongoing projects. The focus lies on transparent processes, clearly defined responsibilities, and technically sound evaluations.<\/p>\n<p>Our support can address specific topics or extend across multiple project phases.<\/p>\n<h4>\u00a0Product concept and feasibility phase<\/h4>\n<ul>\n<li>Feasibility assessments and research for new medical devices<\/li>\n<li>Development of business plans<\/li>\n<\/ul>\n<h4>Product development and technical documentation<\/h4>\n<ul>\n<li>Establishing the technical documentation<\/li>\n<li>Defining essential safety and performance requirements<\/li>\n<li>Organising risk management<\/li>\n<li>Conducting system, design, and process risk analyses<\/li>\n<\/ul>\n<h4>Supply chain and quality structure<\/h4>\n<ul>\n<li>Supplier evaluations<\/li>\n<li>Supplier audits<\/li>\n<\/ul>\n<h4>Verification, validation, and testing<\/h4>\n<ul>\n<li>Product validation<\/li>\n<li>Packaging validation<\/li>\n<li>Process validation (DQ, IQ, OQ, PQ)<\/li>\n<li>Packaging integrity testing<\/li>\n<li>Accelerated aging studies<\/li>\n<li>Transport simulation<\/li>\n<\/ul>\n<h4>Preclinical evaluation and test coordination<\/h4>\n<ul>\n<li>Planning of biocompatibility evaluations<\/li>\n<li>Preparation of risk-based test plans<\/li>\n<li>Coordination of testing activities with qualified laboratories<\/li>\n<li>Evaluation of test results and preparation of reports<\/li>\n<\/ul>\n<h4>Clinical evaluation<\/h4>\n<ul>\n<li>\u00a0Conducting and documenting clinical evaluations<\/li>\n<\/ul>\n<h4>Quality systems and internal organisation<\/h4>\n<ul>\n<li>Alignment of governing documents with current regulatory requirements<\/li>\n<li>Conducting internal training<\/li>\n<li>Gap analysis of existing documentation and evidence<\/li>\n<\/ul>\n<p>In delivering our services, we apply the following regulatory and normative requirements relevant to medical technology:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\">ISO 13485 Medical devices \u2013 Quality management systems \u2013 Requirements 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\/eli\/reg\/2017\/745\" target=\"_blank\" rel=\"noopener\">Medical Device Regulation (EU) 2017\/745 (MDR)<\/a><\/li>\n<li>Regulatory requirements for medical devices in <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/de\/home\/medizinprodukte.html\" target=\"_blank\" rel=\"noopener\">CH<\/a>, <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector_en\" target=\"_blank\" rel=\"noopener\">EU<\/a>, <a href=\"https:\/\/www.fda.gov\/medical-devices\" target=\"_blank\" rel=\"noopener\">USA<\/a> and <a href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" target=\"_blank\" rel=\"noopener\">UK<\/a><\/li>\n<li><a href=\"https:\/\/www.iso.org\/standard\/72704.html\" target=\"_blank\" rel=\"noopener\">ISO 14971 Application of risk management to medical devices<\/a><\/li>\n<li><a href=\"https:\/\/www.iso.org\/standard\/10993-1\" target=\"_blank\" rel=\"noopener\">ISO 10993 series \u2013 Biological evaluation of medical devices<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and\" target=\"_blank\" rel=\"noopener\">FDA Guidance \u00abBiological evaluation of medical devices\u00bb<\/a><\/li>\n<\/ul>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul><\/ul>\n<\/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 over the long term.<\/p>\n<\/div>\n<p><img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/05\/gerhard-dariz_quote.png\" alt=\"\"><br \/>\n<img decoding=\"async\" src=\"\/wp-content\/uploads\/2026\/05\/gerhard-dariz_quote.png\" alt=\"\"><\/p>\n<h2>Next step<\/h2>\n<div>\n<p>We are pleased to review your current quality engineering situation and jointly define the most appropriate support for your organisation.<\/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\":\"Quality Engineering in MedTech: Systematically integrating quality into development and production\",\"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>Quality engineering in medical technology establishes the methodological foundation for systematically implementing quality requirements across the entire lifecycle of a medical device - from development to end-of-life.<\/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 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Gerhard\",\"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\":3185}},\"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\"}}}},{\"type\":\"grid_item\",\"props\":{\"link_text\":\"About Bj\u00f6rn\",\"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\":3190}},\"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\"},{\"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>Medical devices are developed in an environment with stringent requirements for safety, functionality, and regulatory traceability. In addition to the technical performance of a product, the quality of the underlying development and manufacturing processes therefore plays a critical role.<\/p>\n\n\\n\n\n<p>Quality engineering in medical technology provides the methods and structures needed to consistently address quality requirements throughout the product lifecycle.<\/p>\n\n\\n\n\n<p>Early integration of quality-driven methods reduces uncertainties in the development process and facilitates the subsequent assessment of product and process quality. Without such a structured approach, projects often require additional testing, adjustments, or repeated development cycles.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"text_style\":\"lead\"}},{\"type\":\"headline\",\"props\":{\"content\":\"What is meant by Quality Engineering in MedTech\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>The term Quality Engineering (QE) in MedTech describes the application of systematic methods for designing and evaluating product and process quality. At its core is the question of how technical solutions can be developed in a way that defined quality requirements are reliably and reproducibly met.<\/p>\n\n\\n\n\n<p>In the field of medical technology, this includes, among others, structured development processes, risk analyses, qualifications, as well as the validation of manufacturing processes and the product itself. Quality methods are directly integrated into development and production activities.<\/p>\n\n\\n\n\n<p>Quality Engineering links product development with the requirements of a quality management system. At the same time, it provides a foundation for the transparent and traceable implementation of regulatory requirements related to documentation, evidence, and risk assessment.<\/p>\n\n\",\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\"}},{\"type\":\"headline\",\"props\":{\"content\":\"Typical challenges in quality engineering in the MedTech\",\"image_align\":\"left\",\"image_margin\":\"xsmall\",\"title_element\":\"h2\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<div>The development of medical devices often takes place under significant pressure to innovate. At the same time, extensive requirements for documentation, risk management, and process evidence must be fulfilled. This combination leads to organisational and technical challenges in many projects.<\/div>\n\n\\n\n\n<p>A key difficulty lies in aligning technical development decisions with the necessary quality and regulatory evidence. Changes to product design or manufacturing processes can require substantial updates to risk analyses, testing strategies, and documentation.<\/p>\n\n\\n\n\n<p>As multiple disciplines are typically involved, an additional level of complexity arises. Without aligned methods and clearly defined processes, information gaps or inconsistent assessments of risks and requirements can occur.<\/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>Our work is focused on supporting development projects through clearly structured quality methods.<\/p>\n\n\\n\n\n<p>A key focus lies on linking requirements, risks, verification\/validation activities, and decisions in a transparent and traceable manner. This creates a robust foundation for development decisions and subsequent regulatory assessments.<\/p>\n\n\\n\n\n<p>In addition, we support companies in integrating quality methods as simply as possible into their project workflows, enabling efficient application by all involved teams. As a result, quality activities become an integral part of the development process.<\/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 manufacturers of medical devices seeking to structure or further develop their development and manufacturing processes in a systematic manner.<\/p>\n\n\\n\n\n<p>Typical points of contact include professionals responsible for development, quality management, or production, as well as members of executive management. We often work with interdisciplinary teams in which technical, regulatory, and organisational aspects are addressed jointly.<\/p>\n\n\\n\n\n<p>Our services are suitable both for smaller organisations, including start-ups with limited Quality Engineering resources, and for companies with established quality systems that aim to further develop and optimise their processes.<\/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<p>Our services focus on the structured and practical application of quality methods in development and manufacturing projects.<\/p>\n\n\\n\n\n<p>We support companies both in the methodological planning of quality activities and in their practical implementation within ongoing projects. The focus lies on transparent processes, clearly defined responsibilities, and technically sound evaluations.<\/p>\n\n\\n\n\n<p>Our support can address specific topics or extend across multiple project phases.<\/p>\n\n\\n\n\n<h4>\u00a0Product concept and feasibility phase<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Feasibility assessments and research for new medical devices<\/li>\n\n\\n\n\n<li>Development of business plans<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Product development and technical documentation<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Establishing the technical documentation<\/li>\n\n\\n\n\n<li>Defining essential safety and performance requirements<\/li>\n\n\\n\n\n<li>Organising risk management<\/li>\n\n\\n\n\n<li>Conducting system, design, and process risk analyses<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Supply chain and quality structure<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Supplier evaluations<\/li>\n\n\\n\n\n<li>Supplier audits<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Verification, validation, and testing<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Product validation<\/li>\n\n\\n\n\n<li>Packaging validation<\/li>\n\n\\n\n\n<li>Process validation (DQ, IQ, OQ, PQ)<\/li>\n\n\\n\n\n<li>Packaging integrity testing<\/li>\n\n\\n\n\n<li>Accelerated aging studies<\/li>\n\n\\n\n\n<li>Transport simulation<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Preclinical evaluation and test coordination<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Planning of biocompatibility evaluations<\/li>\n\n\\n\n\n<li>Preparation of risk-based test plans<\/li>\n\n\\n\n\n<li>Coordination of testing activities with qualified laboratories<\/li>\n\n\\n\n\n<li>Evaluation of test results and preparation of reports<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Clinical evaluation<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>\u00a0Conducting and documenting clinical evaluations<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<h4>Quality systems and internal organisation<\/h4>\n\n\\n\n\n<ul>\\n\n\n<li>Alignment of governing documents with current regulatory requirements<\/li>\n\n\\n\n\n<li>Conducting internal training<\/li>\n\n\\n\n\n<li>Gap analysis of existing documentation and evidence<\/li>\n\n\\n<\/ul>\n\n\\n\n\n<p>In delivering our services, we apply the following regulatory and normative requirements relevant to medical technology:<\/p>\n\n\\n\n\n<ul>\\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 \u2013 Requirements 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\/eli\/reg\/2017\/745\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">Medical Device Regulation (EU) 2017\/745 (MDR)<\/a><\/li>\n\n\\n\n\n<li>Regulatory requirements for medical devices in <a href=\\\"https:\/\/www.swissmedic.ch\/swissmedic\/de\/home\/medizinprodukte.html\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">CH<\/a>, <a href=\\\"https:\/\/health.ec.europa.eu\/medical-devices-sector_en\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">EU<\/a>, <a href=\\\"https:\/\/www.fda.gov\/medical-devices\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">USA<\/a> and <a href=\\\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">UK<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.iso.org\/standard\/72704.html\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">ISO 14971 Application of risk management to medical devices<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.iso.org\/standard\/10993-1\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">ISO 10993 series \u2013 Biological evaluation of medical devices<\/a><\/li>\n\n\\n\n\n<li><a href=\\\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and\\\" target=\\\"_blank\\\" rel=\\\"noopener\\\">FDA Guidance \u00abBiological evaluation of medical devices\u00bb<\/a><\/li>\n\n\\n<\/ul>\n\n\\n\n\n<ul>\\n\n\n<li style=\\\"list-style-type: none;\\\">\\n\n\n<ul><\/ul>\n\n\\n<\/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 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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,\"padding_top\":\"large\",\"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 over 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    margin-bottom: -16px !important;\\n}\\n\\n@media (max-width: 650px) {\\n    .el-element {\\n        margin-bottom: -8px !important;\\n    }\\n}\",\"image\":\"wp-content\/uploads\/2026\/05\/gerhard-dariz_quote.png\",\"image_svg_color\":\"emphasis\",\"image_width\":750,\"margin\":\"default\",\"margin_bottom\":\"default\",\"margin_top\":\"default\",\"position\":\"relative\",\"position_z_index\":\"1\",\"visibility\":\"hidden-m\"},\"name\":\"Bild \u2013 Mobile\"},{\"type\":\"image\",\"props\":{\"css\":\".el-element {\\n\\tmargin-bottom:-15px !important;\\n}\",\"image\":\"wp-content\/uploads\/2026\/05\/gerhard-dariz_quote.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 30px 50px 50px;\\n}\\n\\n@media (min-width: 960px) {\\n    .uk-card-primary {\\n    \\tborder-radius:5px;\\n\\t\\tpadding:100px 200px 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\"}},{\"type\":\"text\",\"props\":{\"column_breakpoint\":\"m\",\"content\":\"\n\n<p>We are pleased to review your current quality engineering situation and jointly define the most appropriate support for your organisation.<\/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\":\"\",\"icon_align\":\"right\",\"link\":\"kontakt\/\"}}]}]}]}],\"name\":\"Mitarbeiter Zitat\"}],\"version\":\"5.0.32\"} --><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Quality Engineering in MedTech: Systematically integrating quality into development and production Quality engineering in medical technology establishes the methodological foundation for systematically implementing quality requirements across the entire lifecycle of a medical device &#8211; from development to end-of-life. Your contacts Medical devices are developed in an environment with stringent requirements for safety, functionality, and regulatory [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3648,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3650","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3650","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=3650"}],"version-history":[{"count":14,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3650\/revisions"}],"predecessor-version":[{"id":4071,"href":"https:\/\/www.inmedis.ch\/en\/wp-json\/wp\/v2\/pages\/3650\/revisions\/4071"}],"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=3650"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}