{"id":1866,"date":"2025-10-20T20:29:32","date_gmt":"2025-10-20T20:29:32","guid":{"rendered":"https:\/\/eaamedconsulting.com\/?page_id=1866"},"modified":"2026-01-07T10:48:38","modified_gmt":"2026-01-07T10:48:38","slug":"servicios","status":"publish","type":"page","link":"https:\/\/eaamedconsulting.com\/en\/servicios\/","title":{"rendered":"Services"},"content":{"rendered":"
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Services<\/h1>\t\t\t\t<\/div>\n\t\t\t\t
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Advice to companies, offering comprehensive support to ensure compliance, quality and\nconfidence at every stage of the product.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tContact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\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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Quality Systems (ISO 13485)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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Implementation and maintenance of quality management systems in accordance with ISO 13485, ensuring efficient processes that comply with applicable requirements.<\/span><\/p>

Services include:<\/b><\/p>

  • Implementation and maintenance of Quality Management Systems under ISO 13485.<\/span><\/li>
  • Internal audits.<\/span><\/li>
  • Preparation and support during audits with Notified Bodies (NB) and competent authorities.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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    Medical Devices \u2013 European Regulation (MDR)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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    Full regulatory support for CE marking of medical devices in accordance with Regulation (EU) 2017\/745 (MDR). Comprehensive coverage of medical devices of any class and technology, including hardware, software, legacy products, and those covered by Annex XVI.<\/span><\/p>

    Services include:<\/b><\/p>

    • Product classification and determination of the applicable regulatory route.<\/span><\/li>
    • Identification and application of harmonised standards and relevant technical regulations.<\/span><\/li>
    • Preparation and maintenance of technical documentation.<\/span><\/li>
    • Development of clinical evaluation documentation (CEP, CER).<\/span><\/li>
    • Development of post-market surveillance documentation (PMS, PSUR, PMCF).<\/span><\/li>
    • Compliance with and justification of General Safety and Performance Requirements (GSPR).<\/span><\/li>
    • Risk management in accordance with ISO 14971.<\/span><\/li>
    • Development of software documentation (IEC 62304), including the assessment of the applicability of artificial intelligence, cybersecurity and other relevant technical standards.<\/span><\/li>
    • Accompaniment and support in audits and regulatory review processes.<\/span><\/li><\/ul>\t\t\t\t\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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      In Vitro Diagnostic Medical Devices \u2013 European Regulation (IVDR)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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      Through a network of specialized collaborators, EAA Med Consulting provides full regulatory support for IVD products, aligned with Regulation (EU) 2017\/746 (IVDR).<\/span><\/p>

      Services include:<\/b><\/p>

      • Preparation and maintenance of Technical Documentation under IVDR.<\/span><\/li>
      • Definition of regulatory strategy and product classification.<\/span><\/li>
      • Development of performance evaluation and post-market surveillance documentation.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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        International Markets<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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        Regulatory and strategic support for market expansion beyond the European Union, adapting documentation and processes to meet country-specific requirements.<\/span><\/p>

        Services include:<\/b><\/p>

        • Identification of applicable regulatory requirements and definition of market access strategy.<\/span><\/li>
        • Support with local representatives or authorized agents in the target country.<\/span><\/li>
        • For the U.S. market, regulatory guidance for Pre-Submissions, 510(k), and De Novo applications in accordance with FDA requirements.<\/span><\/li>
        • Assistance with document adaptation and regulatory compliance for UK and Latin American markets.<\/span><\/li><\/ul>\t\t\t\t\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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          Tailored Consulting<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
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          Tailored consultancy, adaptable to the needs of each project, ideal for technical or regulatory support at key moments.<\/span><\/p>

          Modalidades:<\/b><\/p>

          • Review of technical or clinical documentation.<\/span><\/li>
          • Support during audits, inspections, or responses to NC reports.<\/span><\/li>
          • Regulatory and strategic advice for launches, modifications, or market expansion.<\/span><\/li>
          • Customized training sessions for regulatory and quality teams.<\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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            Servicios Asesoramiento a empresas, ofreciendo soporte integral para asegurar conformidad. Contactar Sistemas de Calidad (ISO 13485) Implementaci\u00f3n y mantenimiento de sistemas de gesti\u00f3n de la calidad seg\u00fan ISO 13485, asegurando procesos eficientes y conformes con los requisitos aplicables. Servicios incluidos: Implementaci\u00f3n y mantenimiento del Sistemas de Gesti\u00f3n de Calidad bajo ISO 13485. Auditor\u00edas internas. Preparaci\u00f3n […]<\/p>","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1866","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/pages\/1866","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/comments?post=1866"}],"version-history":[{"count":43,"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/pages\/1866\/revisions"}],"predecessor-version":[{"id":2278,"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/pages\/1866\/revisions\/2278"}],"wp:attachment":[{"href":"https:\/\/eaamedconsulting.com\/en\/wp-json\/wp\/v2\/media?parent=1866"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}