{"id":698,"date":"2022-09-05T11:52:00","date_gmt":"2022-09-05T14:52:00","guid":{"rendered":"https:\/\/qccert.com.br\/?p=698"},"modified":"2026-06-01T17:36:48","modified_gmt":"2026-06-01T20:36:48","slug":"qc-news-33-importancia-da-regulamentacao-de-equipamentos-medicos-e-alteracoes-de-produto-ja-certificado","status":"publish","type":"post","link":"https:\/\/qccert.com.br\/en\/qc-news-33-importancia-da-regulamentacao-de-equipamentos-medicos-e-alteracoes-de-produto-ja-certificado\/","title":{"rendered":"QC News #33: Import\u00e2ncia da regulamenta\u00e7\u00e3o de equipamentos m\u00e9dicos e Altera\u00e7\u00f5es de produto j\u00e1 certificado"},"content":{"rendered":"<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-dc0687475c25edd708661a9ead24379b\">\n.avia-section.av-av_section-dc0687475c25edd708661a9ead24379b{\nbackground-color:#ffffff;\nbackground-image:unset;\n}\n.avia-section.av-av_section-dc0687475c25edd708661a9ead24379b .av-section-color-overlay{\nopacity:0.3;\nbackground-image:url(https:\/\/digiocean.com.br\/wp-content\/uploads\/2024\/01\/QCert-1.png);\nbackground-repeat:repeat;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-av_section-dc0687475c25edd708661a9ead24379b main_color avia-section-default avia-no-border-styling  avia-builder-el-0  avia-builder-el-no-sibling  avia-bg-style-scroll av-section-color-overlay-active container_wrap sidebar_left'  ><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-small units'><div class='post-entry post-entry-type-page post-entry-698'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551\">\n#top .av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551{\npadding-bottom:20px;\ncolor:#000000;\nfont-size:40px;\n}\nbody .av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 .av-special-heading-tag{\nfont-size:40px;\n}\n.av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 .special-heading-inner-border{\nborder-color:#000000;\n}\n.av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lvdxux3e-78e86c43f94c54cee7cf3cc8dade0551 av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-1  el_before_av_image  avia-builder-el-first  av-thin-font av-inherit-size'><h2 class='av-special-heading-tag'  itemprop=\"headline\"  ><strong>A IMPORT\u00c2NCIA DA REGULAMENTA\u00c7\u00c3O DE EQUIPAMENTOS M\u00c9DICOS<\/strong><\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxvqq2-314f0c91d554d6b4ad08667f3c0c28fa\">\n.avia-image-container.av-lvdxvqq2-314f0c91d554d6b4ad08667f3c0c28fa img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lvdxvqq2-314f0c91d554d6b4ad08667f3c0c28fa .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-lvdxvqq2-314f0c91d554d6b4ad08667f3c0c28fa av-styling- avia-align-center  avia-builder-el-2  el_after_av_heading  el_before_av_textblock'   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-705 avia-img-lazy-loading-not-705 avia_image' src=\"https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1.jpg\" alt='' title='1661346048049-300x300'  height=\"300\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1.jpg 300w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1-80x80.jpg 80w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1-12x12.jpg 12w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1-36x36.jpg 36w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1-180x180.jpg 180w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1-24x24.jpg 24w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/1661346048049-300x300-1-48x48.jpg 48w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxwkrq-a7b472f2d0797f57b6d53a1d54d4713a\">\n#top .av_textblock_section.av-lvdxwkrq-a7b472f2d0797f57b6d53a1d54d4713a .avia_textblock{\nfont-size:18px;\ncolor:#000000;\n}\n<\/style>\n<section  class='av_textblock_section av-lvdxwkrq-a7b472f2d0797f57b6d53a1d54d4713a'   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center;\">Com novas tecnologias e inova\u00e7\u00f5es surgindo nos \u00faltimos anos, a regulamenta\u00e7\u00e3o brasileira tem exigido um controle maior e melhor de produtos nacionais e internacionais. O mesmo se d\u00e1 na \u00e1rea de equipamentos m\u00e9dicos, com o requerimento de certifica\u00e7\u00f5es e registros.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/www.linkedin.com\/feed\/update\/urn:li:activity:6968190376549466112\/\">Confira aqui<\/a> o conte\u00fado compartilhado por nossos parceiros da <a href=\"https:\/\/medicalfair-brasil.com.br\/\">Medical Fair Brasil<\/a>\u00a0mencionando a import\u00e2ncia da regulamenta\u00e7\u00e3o para equipamentos m\u00e9dicos!<\/p>\n<p style=\"text-align: center;\">D\u00favidas sobre o processo de certifica\u00e7\u00e3o Inmetro de produtos m\u00e9dicos e sistemas de gest\u00e3o? Conte com a QC!<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-3cdc9664f29087702913853352eac422\">\n#top .hr.hr-invisible.av-av_hr-3cdc9664f29087702913853352eac422{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-av_hr-3cdc9664f29087702913853352eac422 hr-invisible  avia-builder-el-4  el_after_av_textblock  el_before_av_heading'><span class='hr-inner'><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72\">\n#top .av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72{\npadding-bottom:20px;\ncolor:#000000;\nfont-size:40px;\n}\nbody .av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 .av-special-heading-tag{\nfont-size:40px;\n}\n.av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 .special-heading-inner-border{\nborder-color:#000000;\n}\n.av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lvdxwvfm-1bbe09c151a0ea91a43b8710c0659d72 av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-5  el_after_av_hr  el_before_av_image  av-thin-font av-inherit-size'><h2 class='av-special-heading-tag'  itemprop=\"headline\"  ><strong>MEU PRODUTO SOFREU ALTERA\u00c7\u00d5ES. E AGORA?<\/strong><\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxxhhc-4970c3a0a31a9b753c10ea24368d5461\">\n.avia-image-container.av-lvdxxhhc-4970c3a0a31a9b753c10ea24368d5461 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lvdxxhhc-4970c3a0a31a9b753c10ea24368d5461 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-lvdxxhhc-4970c3a0a31a9b753c10ea24368d5461 av-styling- avia-align-center  avia-builder-el-6  el_after_av_heading  el_before_av_textblock'   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-706 avia-img-lazy-loading-not-706 avia_image' src=\"https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/Produto-mudou_-que-fazer-300x169-1.png\" alt='' title='Produto-mudou_-que-fazer-300x169'  height=\"169\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/Produto-mudou_-que-fazer-300x169-1.png 300w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/Produto-mudou_-que-fazer-300x169-1-18x10.png 18w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/Produto-mudou_-que-fazer-300x169-1-24x14.png 24w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/Produto-mudou_-que-fazer-300x169-1-36x20.png 36w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/Produto-mudou_-que-fazer-300x169-1-48x27.png 48w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxxsyy-3f5196b50e0e3043165ff23c8e594913\">\n#top .av_textblock_section.av-lvdxxsyy-3f5196b50e0e3043165ff23c8e594913 .avia_textblock{\nfont-size:18px;\ncolor:#000000;\n}\n<\/style>\n<section  class='av_textblock_section av-lvdxxsyy-3f5196b50e0e3043165ff23c8e594913'   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center;\">Essa \u00e9 a d\u00favida de muitos clientes no mundo da certifica\u00e7\u00e3o!<\/p>\n<p style=\"text-align: center;\">Sabemos que a tecnologia tem evolu\u00eddo cada dia mais, e essa evolu\u00e7\u00e3o \u00e9 refletida nos produtos certificados. Sendo assim, \u00e9 comum que haja altera\u00e7\u00f5es de projeto, seja para corrigir algum desvio de funcionamento do equipamento, para moderniz\u00e1-lo ou mesmo por motivos estrat\u00e9gicos.<\/p>\n<p style=\"text-align: center;\">N\u00e3o se preocupe! Essas altera\u00e7\u00f5es podem ocorrer a qualquer momento do processo de certifica\u00e7\u00e3o. \ud83d\ude03<\/p>\n<p style=\"text-align: center;\">\u00c9 importante, entretanto, que tais ajustes sejam prontamente comunicados ao OCP respons\u00e1vel pelo projeto. O Organismo poder\u00e1 ent\u00e3o realizar uma nova an\u00e1lise, verificando o impacto das altera\u00e7\u00f5es em rela\u00e7\u00e3o ao produto j\u00e1 certificado. Essa avalia\u00e7\u00e3o determinar\u00e1 se novas a\u00e7\u00f5es ser\u00e3o necess\u00e1rias, como a poss\u00edvel atualiza\u00e7\u00e3o documental, a realiza\u00e7\u00e3o de novos ensaios laboratoriais, bem como valida\u00e7\u00e3o dessa altera\u00e7\u00e3o na auditoria fabril.<\/p>\n<p style=\"text-align: center;\">Vemos aqui qu\u00e3o importante \u00e9 a comunica\u00e7\u00e3o, a qualquer momento, entre solicitante\/fabricante e o OCP. Ela \u00e9 imprescind\u00edvel, agilizando o seu processo de certifica\u00e7\u00e3o e tornando-o mais transparente poss\u00edvel!<\/p>\n<p style=\"text-align: center;\">Os clientes QC contam com esse diferencial! Gostaria de experimentar o jeito QC de certificar?<\/p>\n<p style=\"text-align: center;\">Entre em contato conosco.<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-3cdc9664f29087702913853352eac422\">\n#top .hr.hr-invisible.av-av_hr-3cdc9664f29087702913853352eac422{\nheight:10px;\n}\n<\/style>\n<div  class='hr av-av_hr-3cdc9664f29087702913853352eac422 hr-invisible  avia-builder-el-8  el_after_av_textblock  el_before_av_heading'><span class='hr-inner'><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a\">\n#top .av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a{\npadding-bottom:20px;\ncolor:#000000;\nfont-size:40px;\n}\nbody .av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a .av-special-heading-tag{\nfont-size:40px;\n}\n.av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a .special-heading-inner-border{\nborder-color:#000000;\n}\n.av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lvdxy0pc-ab0042588471748c157ba9c25c02d53a av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-9  el_after_av_hr  el_before_av_image  av-thin-font av-inherit-size'><h2 class='av-special-heading-tag'  itemprop=\"headline\"  ><strong>SETEMBRO AMARELO: PREVEN\u00c7\u00c3O E COMBATE AO SUC\u00cdDIO<\/strong><\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxy7ax-6a7334c1a74369116140816296454532\">\n.avia-image-container.av-lvdxy7ax-6a7334c1a74369116140816296454532 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lvdxy7ax-6a7334c1a74369116140816296454532 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-lvdxy7ax-6a7334c1a74369116140816296454532 av-styling- avia-align-center  avia-builder-el-10  el_after_av_heading  el_before_av_textblock'   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" class='wp-image-704 avia-img-lazy-loading-not-704 avia_image' src=\"https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176-1.png\" alt='' title='26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176'  height=\"176\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176-1.png 300w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176-1-18x12.png 18w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176-1-24x14.png 24w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176-1-36x21.png 36w, https:\/\/qccert.com.br\/wp-content\/uploads\/2024\/04\/26b667_b6e582f57340448da08ce5931b71246f_mv2-300x176-1-48x28.png 48w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lvdxyp4y-6a59f8932f717a33248bbc53fae41c7b\">\n#top .av_textblock_section.av-lvdxyp4y-6a59f8932f717a33248bbc53fae41c7b .avia_textblock{\nfont-size:18px;\ncolor:#000000;\n}\n<\/style>\n<section  class='av_textblock_section av-lvdxyp4y-6a59f8932f717a33248bbc53fae41c7b'   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center;\">A Associa\u00e7\u00e3o Brasileira de Psiquiatria (ABP) e o Conselho Federal de Medicina (CFM) organizam o Setembro Amarelo, em territ\u00f3rio nacional, desde 2014. O lema deste ano \u00e9 \u201cA vida \u00e9 a melhor escolha!\u201d. Para mais informa\u00e7\u00f5es, acesse <a href=\"http:\/\/www.setembroamarelo.com\">www.setembroamarelo.com<\/a>.<\/p>\n<p style=\"text-align: center;\">O Dia Mundial de Preven\u00e7\u00e3o ao Suic\u00eddio \u00e9 celebrado no dia 10 de setembro. No entanto, a campanha de preven\u00e7\u00e3o e combate ao suic\u00eddio ocorre durante o m\u00eas inteiro.<\/p>\n<p style=\"text-align: center;\">O Centro de Valoriza\u00e7\u00e3o da Vida (CVV) oferece ajuda a quem quer e precisa conversar, sob total sigilo, por telefone, email e chat 24 horas todos os dias. Acesse www.cvv.org.br ou ligue para 188.<\/p>\n<p style=\"text-align: center;\">A Equipe QC CERT apoia essa causa. \ud83d\udc9b<\/p>\n<p style=\"text-align: center;\">QC Certifica\u00e7\u00f5es: dando vida \u00e0s grandes ideias<\/p>\n<\/div><\/section>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='after_section_1'  class='main_color av_default_container_wrap container_wrap sidebar_left'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-small units'><div class='post-entry post-entry-type-page post-entry-698'><div class='entry-content-wrapper 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