{"id":593,"date":"2024-11-22T14:32:28","date_gmt":"2024-11-22T14:32:28","guid":{"rendered":"https:\/\/newmeden.sviluppokeyweb.com\/requisiti-regolatori-e-normativi-internazionali\/"},"modified":"2025-02-07T07:59:13","modified_gmt":"2025-02-07T07:59:13","slug":"international-regulatory-and-normative-requirements","status":"publish","type":"page","link":"https:\/\/www.newmedconsulting.com\/en\/international-regulatory-and-normative-requirements\/","title":{"rendered":"INTERNATIONAL REGULATORY AND NORMATIVE REQUIREMENTS"},"content":{"rendered":"

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REGULATORY AFFAIRS SERVICES AND GAP ANALYSIS ISSUANCE<\/strong><\/h1>\n

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We will help you align with the requirements that are set by local and national regulations even outside the European Union<\/strong>.\u00a0 Manufacturing, importing, or distributing medical devices necessitates compliance with specific directives that require in-depth knowledge.<\/p>\n

Among our various services, NewMed Consulting offers Regulatory Affairs<\/strong> assistance, ensuring that the production and commercialization of your medical devices fully comply with legal requirements<\/strong>. Additionally, we provide Gap Analysis<\/strong> services to carefully assess the relationship between the current situation and the desired one.<\/p>\n

Our services also include the registration of medical devices<\/strong> in the Italian Ministry of Health’s Database<\/strong> and Repertory<\/strong>.<\/p>\n

If you desire an expert and in-depth consultation, please fill out the form<\/strong> now!<\/p>\n

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European Commission<\/p>\n

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EU Regulation 2017\/745 MDR (EN \/ IT)<\/p>\n

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Italian Ministry of Health<\/p>\n

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AT THE SERVICE OF ITALIAN AND FOREIGN COMPANIES<\/strong><\/h2>\n

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Our consulting services are not only aimed at Italian private companies<\/strong>, but also at foreign ones<\/strong>. Any company that produces and marketing medical devices<\/strong>, exports<\/strong> or imports<\/strong> them, or that, finally, provides any type of service aimed at the medical sector<\/strong>, can find in NewMed Consulting a reference point.<\/p>\n

Over the years, we have had the opportunity to delve deeply not only into European laws<\/strong> but also into the legislations and regulations in force in many non-EU countries<\/strong> where our clients’ companies have chosen to market their devices. This allows us to guarantee all those who choose us the best possible support in order to expand their customer base and make their product known <\/strong>beyond the Italian and European borders.<\/p>\n

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Would you like more information?
<\/strong>Contact us, our team is at your service.<\/p>\n

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Contact us<\/p>\n

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