{"id":590,"date":"2025-02-04T10:31:06","date_gmt":"2025-02-04T10:31:06","guid":{"rendered":"https:\/\/www.ipn.pt\/?p=590"},"modified":"2025-02-24T18:27:48","modified_gmt":"2025-02-24T18:27:48","slug":"medical-devices","status":"publish","type":"post","link":"https:\/\/www.ipn.pt\/en\/servicos\/medical-devices\/","title":{"rendered":"Medical Devices"},"content":{"rendered":"<p class=\"wp-block-paragraph\">IPN, through its Automation and Systems Laboratory (LAS), is qualified to support your organisation in the certification process for Medical Devices and In Vitro Medical Devices. Based on the needs identified, IPN supports your organisation through a personalised service.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We offer services in the following areas<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">European Companies<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in implementing the requirements of the new European Regulation applicable to Medical Devices \u2013 EU Regulation 2017\/745<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in implementing the requirements of the new European Regulation applicable to in vitro medical devices \u2013 EU Regulation 2017\/746<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in the UDI (Unique Device Identification) process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support with registration on the EUDAMED platform<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in the CE Marking process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in the ANVISA process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apoio no processo FDA<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apoio no processo UK<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in implementing\/updating ISO 13485 and ISO 9001<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apoio t\u00e9cnico-regulamentar para dispositivo eletrom\u00e9dico &amp; software m\u00e9dico:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gap Analysis &#8211; Processo de design e desenvolvimento<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gap Analysis &#8211; Requisitos<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gap Analysis &#8211; Ciberseguran\u00e7a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Usability testing<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Internal audits of the system and\/or product<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Brazilian Companies<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For Brazilian companies interested in exporting their medical or in vitro diagnostic products to the European market, we provide the following services:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in the European CE process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in issuing the Declaration of Conformity<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in the Clinical Assessment process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in conducting clinical trials<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in the Post-Market Monitoring process<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in applying for a notified body<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in appointing a European Representative for Regulatory Compliance (PRRC)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Support in using the Eudamed platform<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Apoio t\u00e9cnico-regulamentar para dispositivo eletrom\u00e9dico &amp; software m\u00e9dico:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gap Analysis &#8211; Processo de design e desenvolvimento<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gap Analysis &#8211; Requisitos<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gap Analysis \u2013 Ciberseguran\u00e7a<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para al\u00e9m dos servi\u00e7os enumerados temos outras solu\u00e7\u00f5es ao seu dispor dentro desta tem\u00e1tica, nomeadamente apoio ao desenvolvimento de dispositivos m\u00e9dicos, para mais informa\u00e7\u00f5es contacte-nos atrav\u00e9s do e-mail medicaldevices@ipn.pt.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Indicators (last 2 years)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">70 Companies supported<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Over 300 participants benefited from training in the regulatory area<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Over 150 medical devices and in vitro diagnostic medical devices placed on the market with CE marking and\/or FDA process<\/p>","protected":false},"excerpt":{"rendered":"<p>O Instituto Pedro Nunes (IPN), atrav\u00e9s do seu Laborat\u00f3rio de Autom\u00e1tica e Sistemas (LAS), est\u00e1 capacitado para apoiar a sua organiza\u00e7\u00e3o no processo de certifica\u00e7\u00e3o de Dispositivos M\u00e9dicos e de [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":826,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_tec_requires_first_save":true,"_EventAllDay":false,"_EventTimezone":"","_EventStartDate":"","_EventEndDate":"","_EventStartDateUTC":"","_EventEndDateUTC":"","_EventShowMap":false,"_EventShowMapLink":false,"_EventURL":"","_EventCost":"","_EventCostDescription":"","_EventCurrencySymbol":"","_EventCurrencyCode":"","_EventCurrencyPosition":"","_EventDateTimeSeparator":"","_EventTimeRangeSeparator":"","_EventOrganizerID":[],"_EventVenueID":[],"_OrganizerEmail":"","_OrganizerPhone":"","_OrganizerWebsite":"","_VenueAddress":"","_VenueCity":"","_VenueCountry":"","_VenueProvince":"","_VenueState":"","_VenueZip":"","_VenuePhone":"","_VenueURL":"","_VenueStateProvince":"","_VenueLat":"","_VenueLng":"","_VenueShowMap":false,"_VenueShowMapLink":false,"_tribe_blocks_recurrence_rules":"","_tribe_blocks_recurrence_description":"","_tribe_blocks_recurrence_exclusions":"","footnotes":""},"categories":[22],"tags":[71],"class_list":["post-590","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-servicos","tag-tecnologia"],"acf":[],"yoast_head":"<!-- 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