{"id":1471,"date":"2025-05-26T15:25:31","date_gmt":"2025-05-26T15:25:31","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?page_id=1471"},"modified":"2025-07-10T14:58:11","modified_gmt":"2025-07-10T14:58:11","slug":"acompanhamento-pos-mercado-e-farmacovigilancia","status":"publish","type":"page","link":"https:\/\/pharmilab.likealot.pt\/en\/acompanhamento-pos-mercado-e-farmacovigilancia\/","title":{"rendered":"Post Market Surveillance and Vigilance"},"content":{"rendered":"
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Post Market Surveillance and Vigilance<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Post-market surveillance (PMS) is a critical component in ensuring the continued safety and performance of medical devices and in vitro diagnostic devices once they are placed on the market. This process is fundamental for identifying and managing any issues that may arise during real-world use, thus ensuring long-term compliance with European regulations, namely MDR (Regulation (EU) 2017\/745) and IVDR (Regulation (EU) 2017\/746).<\/p>

We provide expert consultancy for the implementation of post-market surveillance and post-market clinical follow-up (PMS\/PMCF) systems, helping ensure that your devices remain compliant and safe for end users.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tNeed help or have any questions? Contact us.<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Our services include <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tDevelopment and implementation\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tDevelopment and implementation of PMS\/PMCF systems to continuously monitor device safety and performance\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tManagement and analysis of incidents\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tManagement and analysis of incidents and adverse events, based on data collected during device use\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tSupport in identifying, assessing, and managing risks\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tSupport in identifying, assessing, and managing risks, ensuring timely and effective responses to potential issues\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tManagement of recalls and withdrawals\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tManagement of recalls and withdrawals, including coordination of communication with competent authorities and customers\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tPeriodic surveillance reports\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tPreparation and submission of periodic surveillance reports\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tConsulting\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h4>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tConsultancy in the development of risk mitigation plans and updates to strategies based on surveillance outcomes\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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This service ensures that your devices not only meet initial compliance requirements but also remain safe and effective throughout their lifecycle, strengthening trust and confidence in the market.<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Voltar aos servi\u00e7os Acompanhamento P\u00f3s-Comercializa\u00e7\u00e3o e Vigil\u00e2ncia O acompanhamento p\u00f3s-comercializa\u00e7\u00e3o \u00e9 um componente essencial para garantir a seguran\u00e7a e o desempenho cont\u00ednuo dos dispositivos m\u00e9dicos e de diagn\u00f3stico in vitro ap\u00f3s a sua comercializa\u00e7\u00e3o. Este processo \u00e9 fundamental para identificar e gerir qualquer problema que possa surgir durante o uso do produto, assegurando a sua […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1471","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1471","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/comments?post=1471"}],"version-history":[{"count":7,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1471\/revisions"}],"predecessor-version":[{"id":1771,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1471\/revisions\/1771"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}