Com a publicação da RDC 848/20214, a Anvisa atualizou o regulamento relativo aos requisitos essenciais de segurança e desempenho…
MSC MED stands out for its expertise and ability to manage your registration with ANVISA, FDA or CE Marking, protocols, validations and other technical and regulatory needs.
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.
Planning, conducting and managing activities to prove the performance of the product, through bench tests. It involves the elaboration of test plans, selection of critical cases for each type of test (worst-cases), definition of sampling and minimum performance criteria for the product, based on the conditions of clinical use of the product and on national and international regulations proof of safety and efficacy.
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.
Complete Solutions
We guide your path and carry out activities to obtain permission to sell medical products before Anvisa and international regulatory agencies.
Our customers report having had difficulties in the past because they didn´t understand clearly and directly what is necessary for the approval of the product before Anvisa or other regulatory agencies. Several clients come to us commenting that the scope of regulatory consultancies in general is limited, as they are limited to compiling client documents, rather than actively participating in the preparation and elaboration of regulatory documentation.
With MSC MED it's different. We provide personalized service, guiding companies in the dental-medical-hospital sector in a clear, direct and complete way, actively participating in the preparation of documents as necessary and requested. We do all this with the safety and excellence that your company deserves.
Get in touch, our team has the right solution for you!
Excellence and Pioneering
Our work has proven success. There are hundreds of successful projects, approved by regulatory agencies around the world. We were pioneers in several technical activities carried out in Brazil, and we serve many customers with pioneering and innovative products.
Count on us to help with traditional and innovative projects!
Check out the latest articles on the site.
Com a publicação da RDC 848/20214, a Anvisa atualizou o regulamento relativo aos requisitos essenciais de segurança e desempenho…
“Estabilidade” é um assunto relevante para a comprovação de segurança e eficácia de dispositivos médicos. Quando falamos de aprovação…
A Medicina Personalizada está em pleno desenvolvimento. Uma de suas aplicações é de produtos médicos customizados de acordo com…
mscmed@mscmed.com.br
comercial@mscmed.com.br
+55 (48) 98445-2696 (comercial)
+55 (48) 99608-0064 (operacional)
Escritório Comercial e Hospedagem: Rua Des. Aurélio Feijó, 141, Cj, Boa vista. Curitiba-Pr.
Matriz: SC-401, km 01, 600, Ed. CELTA - João Paulo, Florianópolis - SC, 88030-000
MSC MED © 2024. Todos os direitos reservados. Desenvolvido por @rebecajobs