{"id":1753,"date":"2025-07-23T10:34:00","date_gmt":"2025-07-23T09:34:00","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?p=1753"},"modified":"2025-07-23T10:34:00","modified_gmt":"2025-07-23T09:34:00","slug":"dispositivos-medicos-overview","status":"publish","type":"post","link":"https:\/\/pharmilab.likealot.pt\/en\/2025\/07\/23\/dispositivos-medicos-overview\/","title":{"rendered":"Medical Devices - overview"},"content":{"rendered":"<p class=\"wp-block-paragraph\"><strong>Classification and Regulation<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To ensure the safety and effectiveness of medical devices, they are subject to strict regulation. In the European Union, they are classified into four risk categories (Class I, IIa, IIb, and III), with Class III devices representing higher complexity and risk to the patient.\n\nAll devices must comply with Regulation (EU) 2017\/745 (MDR), which establishes criteria for assessment, CE marking, and post-market surveillance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All devices must comply with Regulation (EU) 2017\/745 (MDR), which establishes criteria for assessment, CE marking, and post-market surveillance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Support for the Medical Device Life Cycle<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Companies that develop, manufacture, or distribute medical devices have an increased responsibility to ensure quality, safety, and compliance with all legal requirements. Additionally, they must maintain an ongoing commitment to innovation and improvement of their products and services, always placing the patient's well-being at the center of their mission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pharmilab, as a consultant specializing in medical devices, supports these organizations in every steps of the product life cycle \u2014 from development and certification to commercialization and post-market surveillance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We offer technical and regulatory support, ensuring compliance with Regulation (EU) 2017\/745 (MDR) and contributing to the implementation of quality management systems, technical files, CE marking, among others.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We help build safer devices, more robust processes, and a more sustainable future for the healthcare sector!<\/p>","protected":false},"excerpt":{"rendered":"<p>Classifica\u00e7\u00e3o e Regulamenta\u00e7\u00e3o Para garantir a seguran\u00e7a e efic\u00e1cia dos dispositivos m\u00e9dicos, estes s\u00e3o sujeitos a regulamenta\u00e7\u00e3o rigorosa. Na Uni\u00e3o Europeia, s\u00e3o classificados em quatro categorias de risco (Classe I, IIa, IIb e III), sendo que os de Classe III representam maior complexidade e risco para o paciente. Todos os dispositivos devem estar em conformidade [&hellip;]<\/p>","protected":false},"author":2,"featured_media":1754,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-1753","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dispositivos-medicos"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts\/1753","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/comments?post=1753"}],"version-history":[{"count":1,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts\/1753\/revisions"}],"predecessor-version":[{"id":1758,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/posts\/1753\/revisions\/1758"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media\/1754"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1753"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/categories?post=1753"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/tags?post=1753"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}