Planning, conducting and managing biosafety verification activities for a medical device in accordance with ISO 10993-1, through a biohazard management process, which involves categorizing the nature of contact between the medical device and the body and analysis of the raw material of the product, its application and the manufacturing process of the medical device.

Conducting the collection, screening and analysis of clinical data referring to the use of medical technologies, in order to assess the safety and effectiveness of a medical device through clinical data available for the product in question or comparable products. Work carried out in accordance with Anvisa's Guides or international regulations.

Design of clinical studies for use for regulatory purposes or in scientific work. Elaboration of a research protocol, submission and monitoring of the approval of the process before Anvisa, Research Ethics Committee (CEP/CONEP) - Plataforma Brasil. Monitoring of clinical trials. Executive management of studies, with negotiation with centers and researchers focused on technical and financial feasibility.

Planning, conducting and managing activities related to proving the stability of the product during the maximum allowed shelf life (validity). Guidance in decisions and labeling information (storage temperature and humidity).

Planning, conducting and managing activities related to proving the compatibility of medical products in an MRI environment, including the execution of physical or virtual tests (computer simulation).

Planning, conducting and managing activities related to the validation of special processes, such as: cleaning, sterilization, additive manufacturing (3D printing), packaging, anodizing/passivation, injection, reprocessing of instruments, among others.

Guidance in conducting activities related to risk management of medical devices, including survey and analysis of risks related to product operation, adverse events, design, usability, among other sources of risk.

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Conducting audits focusing on quality management systems or specific projects.

Condução de simulações computacionais (Finite Element Analysis - FEA) de modelos mecânicos ou biomecânicos com dispositivos médico para o desenvolvimento, verificação do projeto, validação de conceitos, comparação entre produtos e análises de potenciais melhorias em projetos e impacto de mudanças do projeto do produto.