The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In Brazil, it can also become difficult to make a clear distinction between your regulatory strategy and business strategy. For example, if your international sales and marketing executive signs agreements with distributors who lack expertise on the local regulatory approval process, registering and selling your medical products could become a very challenging process. Our consulting services can help your medical device company develop an intelligent, effective strategy to obtain product registration approval and access the medical markets in Brazil. Our robust knowledge of Brazil’s medical device regulations and effective strategic plans have assisted numerous clients with proactively eliminating risks and uncertainty, while maximizing the potential for commercial success. We work closely with our clients to solve their most complex regulatory problems in areas such as product registration, reimbursement, quality compliance, local agent representation, and clinical trials.