{"id":1775,"date":"2025-07-10T15:02:38","date_gmt":"2025-07-10T15:02:38","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?page_id=1775"},"modified":"2025-07-10T15:12:29","modified_gmt":"2025-07-10T15:12:29","slug":"implementacao-da-iso-13485","status":"publish","type":"page","link":"https:\/\/pharmilab.likealot.pt\/en\/implementacao-da-iso-13485\/","title":{"rendered":"Implementation of ISO 13485"},"content":{"rendered":"
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Implementation of ISO 13485<\/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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ISO 13485 is the international reference standard for quality management systems applicable to medical devices. Its implementation is crucial to ensure compliance with European and international regulatory requirements, and it is often a mandatory condition for CE marking and access to markets outside the European Union.<\/p>\n

We offer comprehensive consultancy and support services in implementing, maintaining, and certifying quality management systems (QMS) according to ISO 13485, tailored to the specific needs and scale of your organization.<\/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\tFull QMS\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 a full QMS, including quality policy, risk management, document and record control, supplier management, corrective and preventive actions, among others\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\tProcedures, work instructions, and mandatory records\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 drafting procedures, work instructions, and mandatory records, tailored to the company's reality and context\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\tPreparing and assisting with internal and external audits\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 preparing and assisting with internal and external audits until certification by an accredited body\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\tMaintenance and improvement of the quality system\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\tOngoing support for the maintenance and improvement of the quality system, ensuring compliance over time and preparation for surveillance audits\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Voltar aos servi\u00e7os Implementa\u00e7\u00e3o da ISO 13485 A norma ISO 13485 \u00e9 o padr\u00e3o internacional de refer\u00eancia para sistemas de gest\u00e3o da qualidade aplic\u00e1veis a dispositivos m\u00e9dicos. A sua implementa\u00e7\u00e3o \u00e9 essencial para garantir a conformidade com os requisitos regulamentares europeus e internacionais, al\u00e9m de ser frequentemente uma condi\u00e7\u00e3o obrigat\u00f3ria para a obten\u00e7\u00e3o da marca\u00e7\u00e3o […]<\/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-1775","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1775","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=1775"}],"version-history":[{"count":10,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1775\/revisions"}],"predecessor-version":[{"id":1803,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1775\/revisions\/1803"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1775"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}