{"id":1463,"date":"2025-05-26T15:24:45","date_gmt":"2025-05-26T15:24:45","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?page_id=1463"},"modified":"2025-07-10T13:16:06","modified_gmt":"2025-07-10T13:16:06","slug":"elaboracao-de-documentacao-tecnica","status":"publish","type":"page","link":"https:\/\/pharmilab.likealot.pt\/en\/elaboracao-de-documentacao-tecnica\/","title":{"rendered":"Preparation of Technical Documentation"},"content":{"rendered":"
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Preparation of Technical Documentation<\/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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The thorough preparation of Technical Documentation is essential to demonstrate the conformity of a medical device with the requirements of Regulation (EU) 2017\/745 (MDR) or Regulation (EU) 2017\/746 (IVDR).<\/p>

We support manufacturers, authorised representatives, and other relevant entities in structuring, developing, and reviewing the technical documentation, ensuring full compliance with the standards set by European regulations and notified bodies.<\/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\tComplete Development\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\tComplete development of Technical Documentation, including:

\n\n-General description of the product;
\n-Clinical evaluation;
\n-Risk management;
\n-Manufacturing information and quality control;
\n-Labelling and Instructions for Use (IFU);
\n-Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) data;\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\tReview and Validation\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\tReview and validation of existing documentation, with gap analysis\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\tAssistance\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\tAssistance with the preparation of complementary documentation

\n-Declaration of conformity;
\n-Certificates;
\n-Clinical plans and reports;
\n-Manufacturing records.\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 is tailored to the class and type of device, covering everything from Class I to Class III products, including innovative, combination, custom-made, or reusable devices.<\/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 Elabora\u00e7\u00e3o de Documenta\u00e7\u00e3o T\u00e9cnica A prepara\u00e7\u00e3o rigorosa da Documenta\u00e7\u00e3o T\u00e9cnica \u00e9 essencial para demonstrar a conformidade de um dispositivo m\u00e9dico com os requisitos do Regulamento (UE) 2017\/745 (MDR) ou Regulamento (UE) 2017\/746 (IVDR). Apoiamos fabricantes, representantes autorizados e outras entidades na estrutura\u00e7\u00e3o, desenvolvimento e revis\u00e3o da documenta\u00e7\u00e3o t\u00e9cnica, assegurando que cumpre os […]<\/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-1463","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1463","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=1463"}],"version-history":[{"count":13,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1463\/revisions"}],"predecessor-version":[{"id":1709,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1463\/revisions\/1709"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1463"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}