Regulatory consulting and technical support service for medical device market clearance and safety/efficacy demonstration. Provides guidance on sanitaria registration, clinical evaluation, biocompatibility studies, and compliance with international standards including FDA, ANVISA, and CE marking req...
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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Comprehensive FDA clearance and regulatory consulting service for medical device development. Guides manufacturers through design requirements, testing protocols, and submission processes from concept through commercialization. Supports novel device classifications and first-in-human applications.
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