{"id":6533,"date":"2021-07-07T16:39:50","date_gmt":"2021-07-07T19:39:50","guid":{"rendered":"https:\/\/passarini.com.br\/?p=6533"},"modified":"2021-11-17T15:56:09","modified_gmt":"2021-11-17T18:56:09","slug":"anvisa-quality-system-management","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-quality-system-management\/","title":{"rendered":"Anvisa Quality System Management"},"content":{"rendered":"<h2><b>ANVISA Quality System Management Implementation and Maintenance\u00a0\u00a0<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">If you export medical devices to Brazil, getting <\/span><i><span style=\"font-weight: 400;\"><a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registrationrecord\">ANVISA<\/a> registration<\/span><\/i><span style=\"font-weight: 400;\"> is the first step to making them viable in the market.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/quality-system\/\">ANVISA<\/a> requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the\u00a0 <\/span><i><span style=\"font-weight: 400;\">ISO 13485 Medical Devices<\/span><\/i><i><span style=\"font-weight: 400;\"> Standard.\u00a0<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">ANVISA uses a risk-based categorization system to categorize medical devices into one of four risk groups ranging from Class 1 (low risk) to Class IV (high risk).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">International manufacturers need the services of a local Brazilian Registration Holder (BRH) to facilitate the process of submitting technical files to ANVISA.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">At Passarini, We help you with the implementation and maintenance of ANVISA\u2019s Good Manufacturing Practices in line with the global<\/span> <i><span style=\"font-weight: 400;\">ISO 14971 medical devices<\/span><\/i><span style=\"font-weight: 400;\"> risk management requirements.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Based on the set schedule, and understanding of your company culture we assist you through;\u00a0<\/span><\/h2>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Working with relevant collaborators to facilitate the\u00a0 ANVISA registration process<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Carrying out normative interpretation and implementation based on past experience and focus on the values that will be aggregated.\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Brainstorming with your implementation team to ensure our process is consistent with your company\u2019s work process<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Standardizing procedures consistent with your company\u2019s unique needs<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Offering advanced Quality Management System maintenance training to your team\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Help you establish an internal team of auditors and offering them continuous training\u00a0\u00a0\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">For more information,<a href=\"https:\/\/passarini.com.br\/contato\/\"> feel free to contact us.\u00a0<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ANVISA Quality System Management Implementation and Maintenance\u00a0\u00a0 If you export medical devices to Brazil, getting ANVISA registration is the first step to making them viable in the market.\u00a0 ANVISA requires you to ensure that all your manufacturing locations meet Brazilian Good Manufacturing Practices (GMP) requirements, the local equivalent of the\u00a0 ISO 13485 Medical Devices Standard.\u00a0  [&#8230;]<\/p>\n","protected":false},"author":2,"featured_media":6534,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[49],"tags":[],"class_list":["post-6533","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/6533","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=6533"}],"version-history":[{"count":5,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/6533\/revisions"}],"predecessor-version":[{"id":7511,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/6533\/revisions\/7511"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/6534"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=6533"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=6533"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=6533"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}