{"id":7443,"date":"2021-09-16T14:24:00","date_gmt":"2021-09-16T12:24:00","guid":{"rendered":"https:\/\/www.positrigo.com\/positrigo-certified-for-iso134852016\/"},"modified":"2021-09-16T14:24:00","modified_gmt":"2021-09-16T12:24:00","slug":"positrigo-certified-for-iso134852016","status":"publish","type":"post","link":"https:\/\/www.positrigo.com\/en-gb\/positrigo-certified-for-iso134852016\/","title":{"rendered":"Positrigo certified for ISO13485:2016"},"content":{"rendered":"\n\n\n\n\n\n<section id=\"res-header-image-block_619ca098a7574\" class=\"res-block res-header-image alignfull\">\n  <div class=\"res-header-img-outside mb-4\" data-aos=\"res-fadeIn\">\n\t<div class=\"res-header-height\">\n\t\t\n\t\n\t  <style> \n\t\t  @media only screen and (min-width: 970px) {\n\t\t\t #res-header-image-block_619ca098a7574.res-header-image .layout-1.header-img-height { height: 70vh;}  \n\t\t\t #res-header-image-block_619ca098a7574.res-header-image .layout-1 .res-header-image-vertical-center { top: 72%;} \n\t\t\t   \n\t\t  }\n\t\t  @media only screen and (max-width: 970px) {  \n\t\t\t#res-header-image-block_619ca098a7574.res-header-image .layout-1.header-img-height { height: 55vh;} \n\t\t\t#res-header-image-block_619ca098a7574.res-header-image .layout-1 .res-header-image-vertical-center { top: 55%;} \n\t\t\t    \n\t\t\t  \t\t  }\n\t\t   \n\t\t\t  @media only screen and (min-width: 1280px) {\n\t\t\t\t\t\t\t\t#res-header-image-block_619ca098a7574.res-header-image .layout-1 h1 {font-size: 200%; line-height: 105%;}\t\t\t\t \n\t\t\t\t\t\t\t\t\t\t\t  }   \n\t\t \t  <\/style> \n\t\t\n\t  <div class=\"layout-1 jarallax header-img-height\" data-speed=\"0.6\" style=\"background-color: #fff;\">\n\t\t  \n\t\t\t\t<div class=\"res-header-image-vertical-center\">\n\t\t\t\t\t<div class=\"container-fluid\">\n\t\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"sloganBox\">\n                           <div class=\"row\">\n                             <div class=\"col col-md-10 text-left\">\n\t\t\t\t\t\t\t\t <div class=\"sloganbox-background text-white\" data-aos=\"res-fadeIn\">\n\t\t\t\t\t\t\t\t \n                                                                   <h1 class=\"pb-1\">Positrigo certified for ISO13485:2016<\/h1>\n                                \t\n\t\t\t\t\t\t\t\t \n                                \t\t\t\t\t\t\t\t \n                                \t\n\t\t\t\t\t\t\t\t \n\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t \t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t                 <\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\n                                            <img decoding=\"async\" class=\"jarallax-img img-fluid\" src=\"https:\/\/www.positrigo.com\/wp-content\/uploads\/2021\/11\/header-blog-2-1920x1080.jpg\"  style=\"opacity: 0.8;\" alt=\"\"\/>\n                    \t\t  \n\t\t\t\t\n\t\t   <\/div>\n\t\t\t \n\t \n\n\n\t\t<\/div>\n\t<\/div>\n<\/section>\t\n\n\n\n<section id=\"res-txt-block_619ca0bca7575\" class=\"res-block res-txt layout01 p-no\" style=\"background: transparent;\">\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\n \n\t\t  \n\t\t \t  \n      \n      <div class=\"layout-1 txt-section\">\n\t\t<div class=\"row\">\t\n\t\t\t\n\t\t\n\t\t\t<div class=\"col-md-10 var-1spalten text-left\">\n\t\t\t\t\n\t\t\t\t<div class=\"txt-title-field\">\n\t\n\t\t\t\t\t\n\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t<\/div> \n\t\t\t\t\t\n\t\t\t\t\t<div class=\"txt-textfield postContent pt-md-2\">\n\t\t\t\t\t\t\t\t\t\t  <p>September 27, 2021<\/p>\n<p><strong>Positrigo demonstrates commitment to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.<\/strong><\/p>\n<p><a href=\"http:\/\/www.positrigo.com\/\">Positrigo<\/a>, a Swiss based company developing nuclear medical imaging devices to advance functional imaging, today announced that it has achieved\u00a0<a href=\"https:\/\/www.positrigo.com\/wp-content\/uploads\/2020\/07\/Q8-109044-0001-REV.00-1.pdf\">ISO13485:2016<\/a>\u00a0certification. This ISO certificate specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e. g. technical support).<\/p>\n<p>\u201cThe implementation of ISO 13485:2016 is the best internationally recognized model to help demonstrate that Positrigo has successfully complied to the laws and regulations of the medical devices industry,\u201d states Elena Bernasconi, CARAQA Manager at Positrigo.\u00a0Max Ahnen, Co-founder and COO for Positrigo adds, \u201cthis certification represents an important milestone for our company and reflects the focus we have on risk-based decision making throughout our organization with a commitment to safety and providing a high-quality product.\u201d<\/p>\n<p>Positrigo is an ETH Zurich spin-off, developing ultra-compact Positron Emission Tomography (PET) systems. The company focuses on delivering versatile head PET systems with applications in early dementia diagnosis and other brain related disorders. NeuroLF<sup>\u00ae<\/sup>, the company\u2019s first device, is expected to become commercially available towards the end of 2022.<\/p>\n<p>\u201cThis certification is further evidence of our unwavering commitment to quality and enables Positrigo to continue to develop NeuroLF<sup>\u00ae<\/sup>\u00a0in compliance with the highest standards for safety, product performance and reliability,\u201d concludes Jannis Fischer, CEO for Positrigo. \u201cMaintaining a world-class quality management system is a key goal for Positrigo.\u201d<\/p>\n<p><strong>About\u00a0<\/strong><a href=\"http:\/\/www.positrigo.com\/\"><strong>Positrigo<\/strong><\/a><strong>:<\/strong><\/p>\n<p>Positrigo is a pioneer in nuclear medical imaging technologies. Headquartered in Zurich, Switzerland, the medical device company was founded in 2018 as a spin-off of ETH Zurich. Positrigo\u2019s technology, development, clinical testing and commercialization has been supported by 4FO Venture Partners, Great Filter Ventures, Zurcher Kantonalbank (ZKB), ETH Zurich Foundation, Venture Kick and the European Innovation Council. NeuroLF<sup>\u00ae<\/sup>\u00a0\u2013 the company\u2019s first device \u2013 is an ultra-compact brain PET scanner which has applications in early assessment of causes of dementias, such as Alzheimer\u2019s disease and other brain related disorders. Learn more at\u00a0<a href=\"http:\/\/www.positrigo.com\/\">http:\/\/www.positrigo.com<\/a>\u00a0or follow us on\u00a0<a href=\"http:\/\/www.linkedin.com\/company\/positrigo\">LinkedIn<\/a>.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Positrigo Media Contact:<\/strong><\/p>\n<p>Dr. Stefan Bircher<\/p>\n<p>VP Business Development &amp; Marketing<\/p>\n<p>Phone: +41 44 515 53 38<\/p>\n<p>Email: s&#116;e&#102;an.&#98;&#105;&#114;&#99;h&#101;r&#64;po&#115;it&#114;i&#103;&#111;&#46;&#99;&#111;m<\/p>\n\t\t\t\t\t\t\t\n\t\t\t\t\t<\/div> \n\t\t\t\t\t\n\t\t\t\t\t <div class=\"txt-textfield-btns pt-2 \">\n\t\t\t\t\t\t  \n\t\t\t\t\t<\/div> \n\t\t\t\t\n\t\t\t\t\t\t\n\t\n\t\t\t\t<\/div>\n\n\t\t \n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t\t\t\t\n\t\t <\/div> \t\n\t\t<\/div>\n\t \n\t  \n \n \n\t<\/div>\n<\/section>\n\n","protected":false},"excerpt":{"rendered":"<p>September 27, 2021<br \/>\nPositrigo demonstrates commitment to provide medical devices and related services&#8230;<\/p>\n","protected":false},"author":1,"featured_media":7001,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[18],"tags":[],"class_list":["post-7443","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts\/7443","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/comments?post=7443"}],"version-history":[{"count":0,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts\/7443\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/media\/7001"}],"wp:attachment":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/media?parent=7443"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/categories?post=7443"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/tags?post=7443"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}