Regulatory certification and compliance service for medical devices seeking INMETRO approval in Brazil. Provides consultancy on quality system updates, regulatory documentation, and navigation of Brazilian regulatory requirements including ANVISA, ANATEL, and INMETRO standards.
Manufactured by
Passarini Group
Brazil
Passarini Group assists healthcare companies in all stages of their regulatory compliance, offering full support and guidance with regulatory bodies, from the initial phases until reaching the level of being ready for commercial operation. We offer a range of regulatory services, and in case of need, we can also provide specialized consultancy on specific compliance matters.
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DOMO Salute - Health Regulatory Consulting · Brazil
Regulatory consulting service providing certification and compliance support for medical devices, in vitro diagnostics, and software as a medical device (SaMD) entering the Brazilian market. Manages ANVISA, INMETRO, and ANATEL certification processes, including documentation preparation, registration holder representation, and Good Manufacturing Practice (GMP) guidance to facilitate market approval and entry.
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Regulatory consulting service for Brazilian Good Manufacturing Practices (BGMP) certification of medical devices, in vitro diagnostics, and digital health solutions. Manages documentation preparation, submission, and compliance with ANVISA and INMETRO requirements to facilitate market entry into Brazil.
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GMP certification service for medical devices and healthcare products entering the Brazilian market. Provides regulatory consulting and documentation support to meet ANVISA requirements for medicines, medical devices, cosmetics, and related products. Enables international manufacturers to establish compliant market access through local hosting and registration services.
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