{"id":2827,"date":"2021-10-05T10:10:09","date_gmt":"2021-10-05T07:10:09","guid":{"rendered":"https:\/\/vyp4g2zxbcr.c.updraftclone.com\/laatu-ja-saantely\/"},"modified":"2024-06-03T09:17:36","modified_gmt":"2024-06-03T06:17:36","slug":"quality-and-regulation","status":"publish","type":"page","link":"https:\/\/www.clinipower.fi\/en\/services\/quality-and-regulation\/","title":{"rendered":"Quality and regulation"},"content":{"rendered":"\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-equal\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<p>Success in the health tech field requires functional operational models that are compliant with regulation. Building a quality management system is an important requirement. Quality and regulatory work is broad and versatile: <strong>from us you can get turnkey quality management projects or coaching according to your needs.<\/strong><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<p>Clinipower team has expertise for example from the following regulations and standards:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR, IVDR, MDD, FDA, MDSAP, GMP <\/li>\n\n\n\n<li>ISO 13485, ISO 9001, ISO 14971, ISO 14155, <br>IEC 62304, IEC 62366, IEC 82304, HL7 <\/li>\n<\/ul>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-499968f5 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/www.clinipower.fi\/en\/contact-us\/\">Contact us<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideright\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"209\" height=\"300\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_ulkoistettu_laatupaallikko-209x300.png\" alt=\"\" class=\"wp-image-2676\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_ulkoistettu_laatupaallikko-209x300.png 209w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_ulkoistettu_laatupaallikko.png 438w\" sizes=\"auto, (max-width: 209px) 100vw, 209px\" \/><\/figure>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"outsourced-quality-manager\">Outsourced quality manager<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">A competent quality manager effortlessly to your team<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>Get a professional quality manager easily and cost-effectively as a part of your team through our service.<\/strong> The outsourced quality manager works together with organization management to ensure quality and regulatory compliance. By outsourcing quality manager\u2019s job, you can focus on other core business aspects.<\/p>\n\n\n\n<p>The quality manager handles your organization\u2019s quality affairs comprehensively, including quality management system, risk management, regulatory plan for products, management reviews, and personnel training. The quality manager is your representative for authorities and can offer support for example post-market surveillance and incident reports.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideleft\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"prrc-service\">PRRC-service<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">Person Responsible for Regulatory Compliance as a service<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Medical device manufacturers and authorised representatives need to have a Person Responsible for Regulatory Compliance (PRRC) in their service. The role of PRRC can be outsourced to an external person in some cases.<\/p>\n\n\n\n<p><strong>We offer you a PRRC who fulfills the regulatory requirements and is permanently and continuously at your disposal.<\/strong> Our PRRC-service consists of two parts: checking the regulatory compliance of your organization and the PRRC-function itself. The PRRC-service can be combined to our outsourced quality manager service.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Clinipower_ikonit-05-300x300.png\" alt=\"\" class=\"wp-image-1992\" style=\"width:250px;height:250px\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Clinipower_ikonit-05-300x300.png 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Clinipower_ikonit-05-600x600.png 600w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Clinipower_ikonit-05.png 626w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure>\n<\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideright\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"261\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_hahmot-02-300x261.png\" alt=\"\" class=\"wp-image-2678\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_hahmot-02-300x261.png 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_hahmot-02.png 596w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"quality-management-system-iso13485\">Quality management system ISO 13485<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">Build a functioning quality management system with us<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>A quality management system (QMS) is the most important requirement for manufacturers of CE-marked health tech products or other operators of the supply chain. By building the QMS according to standard ISO 13485, you can demonstrate conformity with regulatory and customer requirements.<\/p>\n\n\n\n<p>Organizational and process development is closely connected to building a QMS. <strong>With our ISO 13485 -project model the QMS can be built both for large organizations and startups.<\/strong><\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideleft\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"risk-management-iso14971\">Risk management ISO 14971<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">Put a spotlight on safety throughout product life cycle<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Medical device risk management is closely connected to ensuring safety of patients and other stakeholder groups. Risk management is a significant part of medical device life cycle. ISO 14971 -standard includes identifying hazards and related hazardous situations, risk analysis, and planning and execution of risk mitigations.<\/p>\n\n\n\n<p><strong>We help implement ISO 14971 risk management into practice and as a part of quality management system.<\/strong><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/riskienhallinta-300x300.png\" alt=\"\" class=\"wp-image-2698\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/riskienhallinta-300x300.png 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/riskienhallinta-600x600.png 600w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/riskienhallinta.png 672w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure>\n<\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideright\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"269\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_elementti-01-300x269.png\" alt=\"\" class=\"wp-image-2682\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_elementti-01-300x269.png 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_elementti-01-768x688.png 768w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_elementti-01.png 901w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/figure>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"audits\">Audits<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">Develop your organization\u2019s practices through audits<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Audits are systematical and objective evaluations of organizational practices: they aim to ensure that the practices are in accordance with regulation, and recognize needed actions for development. Different types of audits are internal, external, and supplier audits.<\/p>\n\n\n\n<p><strong>Quality advisors of Clinipower have broad experience from medical device and quality management system audits: we offer you an independent and fair auditor.<\/strong> We also provide training and support in preparing for audits.<\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideleft\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"ce-mark-and-certification\">CE-mark and certification<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">Place your product successfully on market<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Medical device development needs to consider various aspects before the product can be placed on market. We will walk all the way with you and make sure that your product can be CE-marked and certified.<\/p>\n\n\n\n<p><strong>We can support you for example in defining the intended purpose and classification of your product, creating documentation, and certification processes.<\/strong><\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"238\" height=\"300\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/08\/Clinipower_hahmot-18-238x300.png\" alt=\"\" class=\"wp-image-1666\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/08\/Clinipower_hahmot-18-238x300.png 238w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/08\/Clinipower_hahmot-18.png 275w\" sizes=\"auto, (max-width: 238px) 100vw, 238px\" \/><\/figure>\n<\/div><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-wideright\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column gb-is-vertically-aligned-center\"><div class=\"gb-block-layout-column-inner\"><div class=\"wp-block-image\">\n<figure class=\"aligncenter size-medium\"><img loading=\"lazy\" decoding=\"async\" width=\"209\" height=\"300\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_hahmot-09_valk-209x300.png\" alt=\"\" class=\"wp-image-2695\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_hahmot-09_valk-209x300.png 209w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/10\/Clinipower_hahmot-09_valk.png 438w\" sizes=\"auto, (max-width: 209px) 100vw, 209px\" \/><\/figure>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"clinical-evaluation-services\">Clinical evaluation services<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-text-color has-medium-font-size\" style=\"color:#eb6645\">Clinical evaluation as part of medical device life cycle<\/p>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Clinical evaluation ensures the safety and performance of a medical device. Clinical evaluation is mandatory for devices in all risk classes. In some cases, a clinical investigation is also required to demonstrate conformity. Clinical evaluation continues throughout device life cycle, also after placing on market.<\/p>\n\n\n\n<p><strong>We can assist for example with clinical evaluation plan and report, preparation of clinical testing and collection of post-market data according to your needs.<\/strong><\/p>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"background-color:#f2f2f2;padding-left:4.5%;padding-right:4.5%\" class=\"wp-block-genesis-blocks-gb-container alignfull gb-block-container\"><div class=\"gb-container-inside\"><div class=\"gb-container-content\" style=\"max-width:1110px\">\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"read-more\">Read more<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<section class=\"gb-block-post-grid featuredpost aligncenter\"><div class=\"gb-post-grid-items is-grid columns-3\"><article id=\"post-6205\" class=\"gb-post-grid-item post-6205 post type-post status-publish format-standard has-post-thumbnail hentry category-quality-and-regulation\"><div class=\"gb-block-post-grid-image\"><a href=\"https:\/\/www.clinipower.fi\/en\/how-to-build-a-qms-system-for-medical-devices\/\" rel=\"bookmark\" aria-hidden=\"true\" tabindex=\"-1\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"768\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2025\/07\/eurooppalainen-laaketiede-teknologia-laboratorio-led.webp\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2025\/07\/eurooppalainen-laaketiede-teknologia-laboratorio-led.webp 1024w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2025\/07\/eurooppalainen-laaketiede-teknologia-laboratorio-led-300x225.webp 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2025\/07\/eurooppalainen-laaketiede-teknologia-laboratorio-led-768x576.webp 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/div><div class=\"gb-block-post-grid-text\"><header class=\"gb-block-post-grid-header\"><h3 class=\"gb-block-post-grid-title\"><a href=\"https:\/\/www.clinipower.fi\/en\/how-to-build-a-qms-system-for-medical-devices\/\" rel=\"bookmark\">How to Build a QMS System for Medical Devices?<\/a><\/h3><div class=\"gb-block-post-grid-byline\"><time datetime=\"2026-04-23T09:14:42+03:00\" class=\"gb-block-post-grid-date\" itemprop=\"datePublished\">23.04.2026<\/time><\/div><\/header><div class=\"gb-block-post-grid-excerpt\"><p>Here is the English translation: How to Build a QMS System for Medical Devices? A QMS (Quality Management System) is&hellip;<\/p>\n<\/div><\/div><\/article>\n<article id=\"post-6185\" class=\"gb-post-grid-item post-6185 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en category-usability-and-service-design\"><div class=\"gb-block-post-grid-image\"><a href=\"https:\/\/www.clinipower.fi\/en\/power-of-formative-evaluation-how-to-enhance-health-technology-ux\/\" rel=\"bookmark\" aria-hidden=\"true\" tabindex=\"-1\"><img loading=\"lazy\" decoding=\"async\" width=\"2121\" height=\"1414\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167.jpg\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167.jpg 2121w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167-300x200.jpg 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167-1024x683.jpg 1024w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167-768x512.jpg 768w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167-1536x1024.jpg 1536w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167-2048x1365.jpg 2048w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2023\/12\/iStock-1306208167-600x400.jpg 600w\" sizes=\"auto, (max-width: 2121px) 100vw, 2121px\" \/><\/a><\/div><div class=\"gb-block-post-grid-text\"><header class=\"gb-block-post-grid-header\"><h3 class=\"gb-block-post-grid-title\"><a href=\"https:\/\/www.clinipower.fi\/en\/power-of-formative-evaluation-how-to-enhance-health-technology-ux\/\" rel=\"bookmark\">Power of formative evaluation: How to enhance health technology UX<\/a><\/h3><div class=\"gb-block-post-grid-byline\"><time datetime=\"2026-03-23T11:18:28+03:00\" class=\"gb-block-post-grid-date\" itemprop=\"datePublished\">23.03.2026<\/time><\/div><\/header><div class=\"gb-block-post-grid-excerpt\"><p>Imagine launching a health technology product only to discover that healthcare professionals struggle with basic navigation, or that patients abandon&hellip;<\/p>\n<\/div><\/div><\/article>\n<article id=\"post-5956\" class=\"gb-post-grid-item post-5956 post type-post status-publish format-standard has-post-thumbnail hentry category-news\"><div class=\"gb-block-post-grid-image\"><a href=\"https:\/\/www.clinipower.fi\/en\/managidithwinter-school-2026\/\" rel=\"bookmark\" aria-hidden=\"true\" tabindex=\"-1\"><img loading=\"lazy\" decoding=\"async\" width=\"1280\" height=\"327\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2026\/02\/Managidith-ryhmakuva-2-e1770191349991.jpg\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2026\/02\/Managidith-ryhmakuva-2-e1770191349991.jpg 1280w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2026\/02\/Managidith-ryhmakuva-2-e1770191349991-300x77.jpg 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2026\/02\/Managidith-ryhmakuva-2-e1770191349991-1024x262.jpg 1024w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2026\/02\/Managidith-ryhmakuva-2-e1770191349991-768x196.jpg 768w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><\/a><\/div><div class=\"gb-block-post-grid-text\"><header class=\"gb-block-post-grid-header\"><h3 class=\"gb-block-post-grid-title\"><a href=\"https:\/\/www.clinipower.fi\/en\/managidithwinter-school-2026\/\" rel=\"bookmark\">ManagiDiTHWinter School 2026<\/a><\/h3><div class=\"gb-block-post-grid-byline\"><time datetime=\"2026-02-04T10:50:18+03:00\" class=\"gb-block-post-grid-date\" itemprop=\"datePublished\">04.02.2026<\/time><\/div><\/header><div class=\"gb-block-post-grid-excerpt\"><p>The last week of January was intensive and rewarding for Clinipower, as we participated in the ManagiDiTH Winter School &amp;&hellip;<\/p>\n<\/div><\/div><\/article>\n<\/div><\/section>\n\n\n<div style=\"height:96px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-columns gb-layout-columns-2 gb-2-col-equal\"><div class=\"gb-layout-column-wrap gb-block-layout-column-gap-2 gb-is-responsive-column\">\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<h2 class=\"wp-block-heading\" id=\"our-experts\">Our experts<\/h2>\n\n\n\n<div style=\"height:32px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div style=\"background-color:#f2f2f2;color:#32373c\" class=\"wp-block-genesis-blocks-gb-profile-box round gb-has-avatar gb-font-size-16 gb-block-profile gb-profile-columns\"><div class=\"gb-profile-column gb-profile-avatar-wrap\"><div class=\"gb-profile-image-wrap\"><figure class=\"gb-profile-image-square\"><img loading=\"lazy\" decoding=\"async\" width=\"1360\" height=\"1366\" class=\"gb-profile-avatar wp-image-1811\" src=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Kimmo-min-rajattu.jpg\" alt=\"\" srcset=\"https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Kimmo-min-rajattu.jpg 1360w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Kimmo-min-rajattu-300x300.jpg 300w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Kimmo-min-rajattu-1020x1024.jpg 1020w, https:\/\/www.clinipower.fi\/wp-content\/uploads\/2021\/09\/Kimmo-min-rajattu-768x771.jpg 768w\" sizes=\"auto, (max-width: 1360px) 100vw, 1360px\" \/><\/figure><\/div><\/div><div class=\"gb-profile-column gb-profile-content-wrap\"><h2 class=\"gb-profile-name\" style=\"color:#32373c\">Kimmo Vauhkonen<\/h2><p class=\"gb-profile-title\" style=\"color:#32373c\">Senior advisor, Quality and Regulatory<\/p><div class=\"gb-profile-text\"><\/div><ul class=\"gb-social-links\"><li><a href=\"mail&#116;&#111;&#58;&#107;&#105;&#x6d;&#x6d;&#x6f;&#x2e;&#x76;&#x61;&#x75;hkon&#101;&#110;&#64;&#99;&#108;&#x69;&#x6e;&#x69;&#x70;&#x6f;&#x77;&#x65;&#x72;&#46;fi\" target=\"_blank\" rel=\"noopener noreferrer\" style=\"background-color:#392f43\" aria-label=\"Email\"><svg aria-labelledby=\"gb-link-email-79c4dadb-0596-4657-982b-1440743bb168\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><title id=\"gb-link-email-79c4dadb-0596-4657-982b-1440743bb168\">Email<\/title><path fill=\"#fff\" d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 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768w\" sizes=\"auto, (max-width: 1360px) 100vw, 1360px\" \/><\/figure><\/div><\/div><div class=\"gb-profile-column gb-profile-content-wrap\"><h2 class=\"gb-profile-name\" style=\"color:#32373c\">Raimo Asikainen<\/h2><p class=\"gb-profile-title\" style=\"color:#32373c\">Senior Advisor, Quality<\/p><div class=\"gb-profile-text\"><\/div><ul class=\"gb-social-links\"><li><a href=\"mai&#108;&#116;&#111;&#x3a;&#x72;&#x61;&#x69;&#x6d;&#x6f;&#46;as&#105;&#107;&#97;&#105;&#x6e;&#x65;&#x6e;&#x40;&#x63;&#x6c;ini&#112;&#111;&#119;&#x65;&#x72;&#x2e;&#x66;&#x69;\" target=\"_blank\" rel=\"noopener noreferrer\" style=\"background-color:#392f43\" aria-label=\"Email\"><svg aria-labelledby=\"gb-link-email-0ffaee2e-4b1a-4cd2-89e0-4537c32142fc\" role=\"img\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 512 512\"><title id=\"gb-link-email-0ffaee2e-4b1a-4cd2-89e0-4537c32142fc\">Email<\/title><path fill=\"#fff\" d=\"M464 64H48C21.49 64 0 85.49 0 112v288c0 26.51 21.49 48 48 48h416c26.51 0 48-21.49 48-48V112c0-26.51-21.49-48-48-48zm0 48v40.805c-22.422 18.259-58.168 46.651-134.587 106.49-16.841 13.247-50.201 45.072-73.413 44.701-23.208.375-56.579-31.459-73.413-44.701C106.18 199.465 70.425 171.067 48 152.805V112h416zM48 400V214.398c22.914 18.251 55.409 43.862 104.938 82.646 21.857 17.205 60.134 55.186 103.062 54.955 42.717.231 80.509-37.199 103.053-54.947 49.528-38.783 82.032-64.401 104.947-82.653V400H48z\"><\/path><\/svg><\/a><\/li><\/ul><\/div><\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-genesis-blocks-gb-column gb-block-layout-column\"><div class=\"gb-block-layout-column-inner\">\n<div class=\"pipedriveWebForms\" data-pd-webforms=\"https:\/\/webforms.pipedrive.com\/f\/6We8eUvnaJAxfLznPNoIxkEY8Cgob1US0jW05VUg2VYi1E6C0FP84eZIeGve9Bybpp\"><script src=\"https:\/\/webforms.pipedrive.com\/f\/loader\"><\/script><\/div>\n<\/div><\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:48px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p> [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/www.clinipower.fi\/en\/services\/quality-and-regulation\/\">Read More&#8230;<span class=\"screen-reader-text\"> from Quality and regulation<\/span><\/a><\/p>\n","protected":false},"author":14,"featured_media":2619,"parent":3172,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-2827","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality and regulation - Clinipower Finland Oy<\/title>\n<meta name=\"description\" content=\"Quality and regulation services: QMS, risk management, quality manager, PRRC, audits, CE-certification and 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