Regulatory consulting and market clearance support for medical devices, including safety and efficacy documentation, clinical evaluation protocols, biocompatibility studies, and submission guidance for ANVISA, FDA, and CE marking compliance.
Manufactured by
MSC MED ENGENHARIA E TECNOLOGIA MEDICA LTDA
Florianopolis, Brazil
MSC MED combines scientific expertise with extensive knowledge of the Brazilian, American and European regulatory framework, offering intelligence and methodologies that assist in the development of medical device design, with a focus on ensuring safety and effectiveness to the end user. Focusing on customized customer service, we specialize in guiding companies in the dental - medical - hospital sector to overcome the technical and regulatory barriers applicable while obtaining approval for the commercialization of medical products. The company handles low, medium and high complexity processes, conducting the process partially or completely to obtain regulatory approval.
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East medical Technology (Suzhou) Co., Ltd. · China
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