INTERNATIONAL REGULATORY AND NORMATIVE REQUIREMENTS
REGULATORY AFFAIRS SERVICES AND GAP ANALYSIS ISSUANCE
We will help you align with the requirements that are set by local and national regulations even outside the European Union. Manufacturing, importing, or distributing medical devices necessitates compliance with specific directives that require in-depth knowledge.
Among our various services, NewMed Consulting offers Regulatory Affairs assistance, ensuring that the production and commercialization of your medical devices fully comply with legal requirements. Additionally, we provide Gap Analysis services to carefully assess the relationship between the current situation and the desired one.
Our services also include the registration of medical devices in the Italian Ministry of Health’s Database and Repertory.
If you desire an expert and in-depth consultation, please fill out the form now!
European Commission
EU Regulation 2017/745 MDR (EN / IT)
Italian Ministry of Health
Compliance with local and national regulatory requirements in force in non-EU countries for Manufacturers, Importers and Distributors of medical devices
National and International Regulatory Affairs Services
Issuing of specific gap analyses in case of issuance of revised international Regulations, Standards and Guidelines
Registration of medical devices with Competent Authorities in non-EU countries
AT THE SERVICE OF ITALIAN AND FOREIGN COMPANIES
Our consulting services are not only aimed at Italian private companies, but also at foreign ones. Any company that produces and marketing medical devices, exports or imports them, or that, finally, provides any type of service aimed at the medical sector, can find in NewMed Consulting a reference point.
Over the years, we have had the opportunity to delve deeply not only into European laws but also into the legislations and regulations in force in many non-EU countries 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 beyond the Italian and European borders.
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