{"id":5459,"date":"2024-06-26T09:43:00","date_gmt":"2024-06-26T09:43:00","guid":{"rendered":"https:\/\/perseivivarium.com\/blog\/?p=5459"},"modified":"2024-06-26T09:43:00","modified_gmt":"2024-06-26T09:43:00","slug":"persei-vivarium-obtains-iso-13485-certification-accrediting-quality-management-systems-for-medical-devices","status":"publish","type":"post","link":"https:\/\/perseivivarium.com\/blog\/persei-vivarium-obtains-iso-13485-certification-accrediting-quality-management-systems-for-medical-devices\/","title":{"rendered":"Persei vivarium obtains ISO 13485 certification, accrediting quality management systems for medical devices"},"content":{"rendered":"\n[et_pb_section fb_built=”1″ theme_builder_area=”post_content” _builder_version=”4.25.2″ _module_preset=”default”][et_pb_row _builder_version=”4.25.2″ _module_preset=”default” theme_builder_area=”post_content”][et_pb_column _builder_version=”4.25.2″ _module_preset=”default” type=”4_4″ theme_builder_area=”post_content”][et_pb_text _builder_version=”4.25.2″ _module_preset=”default” theme_builder_area=”post_content” hover_enabled=”0″ sticky_enabled=”0″ custom_margin=”-70px||||false|false”]

Persei vivarium obtains ISO 13485 certification, accrediting quality management systems for medical devices<\/span><\/span><\/h1>\n

by Patricia Dom\u00ednguez, June 26, 2024<\/span><\/span><\/p>[\/et_pb_text][et_pb_image src=”https:\/\/perseivivarium.com\/blog\/wp-content\/uploads\/2024\/06\/Persei-vivarium-obtains-ISO-13485-certification-accrediting-quality-management-systems-for-medical.jpg” _builder_version=”4.25.2″ _module_preset=”default” theme_builder_area=”post_content” hover_enabled=”0″ sticky_enabled=”0″ title_text=”Persei vivarium obtains ISO 13485 certification, accrediting quality management systems for medical”][\/et_pb_image][et_pb_text _builder_version=”4.25.2″ _module_preset=”default” theme_builder_area=”post_content” hover_enabled=”0″ sticky_enabled=”0″]

After a complete and exhaustive auditing process, our company, <\/span>Persei vivarium<\/span><\/a>, has <\/span>obtained the ISO 13485 certification<\/span><\/b> that <\/span>accredits the organization\u2019s quality management system for the design, development, and commercialization of medical device software<\/span><\/b>.<\/span><\/p>\n

The ISO 13485 standard provides a foundation that is applicable to companies in the sector of medical devices and related services, and includes those specifications for quality management systems that <\/span>demonstrate the ability of the organization to provide medical devices that are adapted to the requirements of the client and applicable regulations<\/span><\/b>. The principal elements of the standard are, among others, a focus on risk management, legal and regulatory compliance, continuous improvement, as well as the management and measurement of the product\u2019s operation and procedures.<\/span>\u00a0<\/span><\/p>\n

This certification guarantees that <\/span>our company has in place a solid system for quality management and complies with international regulatory requirements in the medical device industry.<\/span><\/b>\u00a0In addition, it ensures that the organization has the <\/span>necessary expertise to introduce safe medical devices to the market.<\/span><\/b>\u00a0<\/span><\/p>\n

For Persei vivarium, achieving this certification represents another <\/span>step forward in our commitment to safety and quality,<\/span><\/b> as well as the <\/span>continuous improvement of our systems and processes<\/span><\/b>. It allows us to <\/span>offer products and services that meet market needs and comply with regulations<\/span><\/b> in an ever-evolving and highly demanding environment.<\/span><\/p>\n

#QualityManagementSystem <\/span><\/a>#ISO13485<\/span><\/a><\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.16″ custom_padding=”20px|0px|0px|0px” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||” theme_builder_area=”post_content”][et_pb_text _builder_version=”4.16″ global_colors_info=”{}” theme_builder_area=”post_content”]

Share<\/h4>\r[\/et_pb_text][et_pb_code _builder_version=”4.16″ link_option_url_new_window=”on” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_code][et_pb_team_member name=”Patricia Dom\u00ednguez” position=”Business Development” image_url=”https:\/\/perseivivarium.com\/blog\/wp-content\/uploads\/2018\/09\/Patri-2.jpg” _builder_version=”4.25.2″ hover_enabled=”0″ global_colors_info=”{}” theme_builder_area=”post_content” title_text=”Patri” link_option_url=”https:\/\/www.linkedin.com\/in\/patricia-dom%C3%ADnguez-a18b3866\/” link_option_url_new_window=”on” sticky_enabled=”0″]

Persei vivarium<\/p>[\/et_pb_team_member][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"excerpt":{"rendered":"

After a complete and exhaustive auditing process, our company, Persei vivarium, has obtained the ISO 13485 certification that accredits the organization\u2019s quality management system for the design, development, and commercialization of medical device software.<\/p>\n","protected":false},"author":2,"featured_media":5466,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[36,35],"tags":[341,342,343,344,345],"class_list":["post-5459","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-certifications","category-corporate","tag-iso-13485","tag-medical-device","tag-producto-sanitario","tag-quality-management-system","tag-sistemas-de-gestion-de-calidad"],"_links":{"self":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/5459","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/comments?post=5459"}],"version-history":[{"count":6,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/5459\/revisions"}],"predecessor-version":[{"id":5469,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/posts\/5459\/revisions\/5469"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/media\/5466"}],"wp:attachment":[{"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/media?parent=5459"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/categories?post=5459"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/perseivivarium.com\/blog\/wp-json\/wp\/v2\/tags?post=5459"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}