{"id":4128,"date":"2023-10-01T09:50:34","date_gmt":"2023-10-01T16:50:34","guid":{"rendered":"https:\/\/arkelectronics.com\/digital-heroes\/?p=4128"},"modified":"2024-09-18T09:51:46","modified_gmt":"2024-09-18T16:51:46","slug":"ark-electronics-receives-iso-13485-certification-for-medical-equipment-manufacturing","status":"publish","type":"post","link":"https:\/\/arkelectronics.com\/zh-hans\/ark-electronics-receives-iso-13485-certification-for-medical-equipment-manufacturing\/","title":{"rendered":"Ark Electronics Receives ISO 13485 Certification for Medical Equipment Manufacturing"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"4128\" class=\"elementor elementor-4128\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"has_eae_slider elementor-section elementor-top-section elementor-element elementor-element-70d1311 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-eae-slider=\"95798\" data-id=\"70d1311\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_eae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b039fea\" data-eae-slider=\"19664\" data-id=\"b039fea\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-88dbe80 elementor-widget elementor-widget-text-editor\" data-id=\"88dbe80\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>(Irvine, CA) Ark Electronics, a leading <a href=\"https:\/\/arkelectronics.com\/digital-heroes\/\" target=\"_blank\" rel=\"noopener\">global contract manufacturer specializing in end-to-end electronic manufacturing solutions<\/a> (EMS) and PCB Assembly, announced that it has earned the Medical Equipment Quality Management Certification from the Geneva, Switzerland-based International Organization for Standards (ISO).\u00a0 This internationally agreed upon and highly sought-after ISO 13485 standard is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacturing of medical devices.<\/p><p>Earning this certification confirms that Ark Electronics has met all the requirements for a quality management system and demonstrated its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, 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><p>\u201cSafety and quality are non-negotiable\u00a0in the medical devices industry.\u00a0 That\u2019s why we developed the highest-quality manufacturing processes and utilize the most rigorous standards, with a zero-tolerance policy for defects.\u00a0 In doing so, we easily meet the ISO requirements for medical devices,\u201d said Bob Meyerson, CEO of Irvine, CA-based Ark Electronics.\u00a0 \u201cThis ISO certification, along with the many other ISO and independent third-party certifications we have received, gives our clients the assurances they value and deserve when it comes to the quality manufacturing and delivery of their products.\u201d<\/p><p>Ark Electronics&#8217; other <a href=\"https:\/\/arkelectronics.com\/digital-heroes\/quality-assurance-certifications\/\" target=\"_blank\" rel=\"noopener\">ISO Quality Assurance certifications<\/a> include:\u00a0<\/p><ul><li>ISO 9001 &#8211; Quality Management System Certification,<\/li><li>ISO 14001 &#8211; Environmental Management System Certification,<\/li><li>ISO 45001 &#8211; Occupational Health &amp; Safety Certification<\/li><li>ISO 27001 &#8211; Info\u00a0Security Management\u00a0System Certification<\/li><li>NQA: IATF 16949 &#8211; Automotive Quality Management System Certification<\/li><\/ul><p>Located in North America and Asia, Ark Electronics is a global Electronics Manufacturing Services (EMS) provider serving leading consumer electronics, mobile communications, automotive, and industrial IoT companies. We combine technical expertise with agile manufacturing and supply chain processes, enabling our customers to create and supply original products and solutions at scale to their global OEM Customers.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>(Irvine, CA) Ark Electronics, a leading global contract manufacturer specializing in end-to-end electronic manufacturing solutions (EMS) and PCB Assembly, announced that it has earned the Medical Equipment Quality Management Certification from the Geneva, Switzerland-based International Organization for Standards (ISO).  <\/p>\n","protected":false},"author":30,"featured_media":5571,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,14],"tags":[104,105],"class_list":["post-4128","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11","category-press-releases-cn","tag-iso-13485","tag-medical-equipment-manufacturing"],"_links":{"self":[{"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/posts\/4128","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=4128"}],"version-history":[{"count":0,"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/posts\/4128\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/media\/5571"}],"wp:attachment":[{"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=4128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=4128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/arkelectronics.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=4128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}