SilverFit systems are certified medical devices which comply with the requirements of various international standardisation bodies:<\/p>\n
<\/p>\n
But why would you want such a certification? What do you as a customer and user gain by it? <\/p>\n We have gathered all the information on our certifications in an article. Here you will also be able to download the CE mark<\/strong>, the ISO certificate<\/strong> and the Declarations of Conformity <\/strong>(DoC) of all our systems. Also, you will find the links to the European Database on Medical Devices (EUDAMED<\/strong><\/a>) for each system.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" SilverFit systems are certified medical devices which comply with the requirements of various international standardisation bodies: SilverFit medical products comply with the new MDR (Medical Device Regulation) requirements for CE (Conformit\u00e9 Europ\u00e9enne) marking; SilverFit medical products are developed in compliance with the IEC (International Electrotechnical Commission) 62304 standards for medical software. Our working methods are […]<\/p>\n","protected":false},"author":7,"featured_media":13194,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38,59,51,58,60,52],"tags":[194,188,195,189,190,191,192,193],"class_list":["post-13015","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silverfit","category-silverfit-3d-en","category-silverfit-flow-en","category-silverfit-mile-en","category-silverfit-newton-en","category-silverfit-rephagia-en","tag-ce-mark","tag-ce-keurmerk-en","tag-certified-medical-devices","tag-gecertificeerd-en","tag-iec-en","tag-iso-en","tag-mdr-en","tag-medisch-hulpmiddel-en"],"_links":{"self":[{"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/posts\/13015","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/comments?post=13015"}],"version-history":[{"count":4,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/posts\/13015\/revisions"}],"predecessor-version":[{"id":13023,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/posts\/13015\/revisions\/13023"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/media\/13194"}],"wp:attachment":[{"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/media?parent=13015"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/categories?post=13015"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.silverfit.com\/en\/wp-json\/wp\/v2\/tags?post=13015"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\nBuying a certified<\/strong> medical device is important for several key reasons \u2014 mainly around safety, quality, legal compliance, and reliability<\/strong>.
\nHere\u2019s a breakdown:<\/p>\n\n
\n<\/strong>Devices must pass strict safety checks before they\u2019re allowed on the market .We have also a risk management process to reduce the risks for users as far as possible.<\/li>\n
\n<\/strong>Our products are developed based on proven research. We have written a detailed white paper for each product with multiple research and studies that are available on our website for further information.<\/li>\n
\n<\/strong>There is always an updated manual instruction to be found on our systems so you can use it correctly and confidently. Each system is also provided with a label that allows users to identify exactly which product they are using.<\/li>\n
\n<\/strong>Each of our products has a unique identification code, making int easy to determine the exact version in use.<\/li>\n
\n<\/strong>After a system is acquired by a client we still solve cases and follow up on issues and feedback.<\/li>\n
\n<\/strong>Manufacturers follow strict quality rules during production. We have an ISO certified production system that guarantees quality across all products.<\/li>\n
\n<\/strong>Our devices are checked by certified organizations before approval. We are also always open to review of our processes and products if needed. Technical documentation is always available on request.<\/li>\n
\n<\/strong>Patient information must be handled securely and ethically . Therefore we encrypt patient data, we do no have access to patient data of our clients and we reduce the collection of personal information.<\/li>\n
\n<\/strong>Medical software must meet safety rules throughout its development. Our software is developed according to international standards and tested before making it available to customers.<\/li>\n
\n<\/strong>MDR supports transparency, sustainability, and responsible business practices. We have a sustainability system to reduce our impact on the environment, we have an ECOVADIS<\/a> score and we are preparing to get the ISO 27001 certificate<\/a> (implementation of an information security management system that meets the requirements of the international ISO 27001 standard).<\/li>\n<\/ol>\n