{"id":1525,"date":"2025-05-26T15:58:54","date_gmt":"2025-05-26T15:58:54","guid":{"rendered":"https:\/\/pharmilab.likealot.pt\/?page_id=1525"},"modified":"2025-07-10T15:02:11","modified_gmt":"2025-07-10T15:02:11","slug":"apoio-no-desenvolvimento-da-analise-de-risco","status":"publish","type":"page","link":"https:\/\/pharmilab.likealot.pt\/en\/apoio-no-desenvolvimento-da-analise-de-risco\/","title":{"rendered":"Support in Risk Analysis Development"},"content":{"rendered":"
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\tBack to Services<\/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
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Support in Risk Analysis Development<\/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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Risk management is one of the key pillars of medical device regulation and is mandatory under Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR). ISO 14971 sets out a structured approach to identifying, evaluating, controlling, and monitoring the risks associated with a medical device\u2019s lifecycle.<\/p>

We provide specialized technical support in developing and implementing risk management processes, ensuring compliance with ISO 14971 and its integration into the company\u2019s Quality Management System.<\/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\tISO 14971\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\tPlanning and structuring the risk management process according to ISO 14971\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\tDesign, Manufacture, Use, and Disposal\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\tIdentifying and evaluating hazards and potential risks associated with the design, manufacture, use, and disposal of the device\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\tRisk Analysis and Management 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\tDeveloping risk analysis and management reports, including:
\n-Risk management plan;
\n-Risk analysis;
\n-Residual risk evaluation;
\n-Final risk management report;\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\tSupport in Integrating Risk Management\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 integrating risk management with clinical data, production control, and post-market surveillance (PMS and PMCF)\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 Update of Risk Documentation\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\tPeriodic review and update of risk documentation, based on new information, market feedback, or regulatory changes\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 Apoio no desenvolvimento da An\u00e1lise de Risco A gest\u00e3o de risco \u00e9 um dos pilares fundamentais da regulamenta\u00e7\u00e3o dos dispositivos m\u00e9dicos e \u00e9 obrigat\u00f3ria ao abrigo do Regulamento (UE) 2017\/745 (MDR) e do Regulamento (UE) 2017\/746 (IVDR). A norma ISO 14971 estabelece a abordagem estruturada para identificar, avaliar, controlar e monitorizar 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-1525","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1525","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=1525"}],"version-history":[{"count":7,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1525\/revisions"}],"predecessor-version":[{"id":1774,"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/pages\/1525\/revisions\/1774"}],"wp:attachment":[{"href":"https:\/\/pharmilab.likealot.pt\/en\/wp-json\/wp\/v2\/media?parent=1525"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}