Certificates
We are a technology company operating in the medical field. Our innovative solutions are revolutionizing the way people’s lives can be treated and saved.
We are developing technologies that support diagnostic imaging and next-generation digital medicine. Our solutions have already received certification in MedApp’s key markets.
CE
CE is a marking placed on the product of a manufacturer whose product has been approved for marketing in the European Union. CE directives concern issues related to safety of use, health protection and environmental protection. By marking its product with the CE mark, the manufacturer declares that the product complies with the requirements of all directives relating to it. As a result, CarnaLife Holo and CarnaLife System software can be supplied to medical facilities throughout the European Union.
ANVISA
ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian Health Regulatory Agency, is a cell affiliated with the Ministry of Health that coordinates the operation of the Brazilian Health Regulatory System (SNVS). MedApp S.A. holds certification issued by the Agency for the CarnaLife Holo software in Brazil.
FDA
The FDA (Food and Drug Administration), is the U.S. Food and Drug Administration that inspects food products, drugs and medical devices. In June 2022, MedApp submitted an application to the FDA to begin selling CarnaLife Holo software in the US market. The application is for the approval of CLH’s holographic medical data visualization technology. The approval process is being managed by a partner, Parexel International, which is experienced in this field. In May 2023, MedApp received FDA confirmation of compliance and thus CarnaLife Holo technology was approved for the US market.
NATO OTAN
We hold the NATO Commercial and Government Entity (NCAGE) code. This means that MedApp S.A. software meets the requirements specified in the NATO Manual for Codification – ACodP-1 guidelines. The NCAGE certificate allows us to provide services or deliveries to NATO member states.
