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Expertise | Excelence | Commitment

Safety and Efficacy of Medical Products Regulatory Affairs Market Clearance for Medical Devices Avaliação e Investigação Clínica MRI Environment Compatibility Validation of Manufacturing Processes Biological Evaluation |

Expertise | Excelence | Commitment

Registration Hosting de Produtos Médicos Regulatory Affairs Market Clearance for Medical Devices Avaliação e Regulatory Affairs MRI Environment Compatibility Validação de Processos de Fabricação Biological Evaluation |

Proven success

The technical staff stands out for having guided and developed the safety and efficacy assessment of hundreds of medical products that have obtained permission for commercialization and use in humans. 

National and International Presence

We have helped Brazilian companies and companies from over 15 countries. Our fully bilingual team serves importers and their partners, as well as manufacturers and international regulatory agencies.

Multidisciplinary Team

Outstanding among our team are engineers with a background in biomechanics and biomaterials, as well as physiotherapists, chemists, biologists and pharmacists with experience in health regulation and who work in the main national and international discussion forums in the area (ISO, ASTM, ABNT). 

Who We Are

Brazilian CRO

MSC MED is a Brazilian CRO specializing in safety and efficacy demonstration and international regulation of medical devices.

70 %
Customer Satisfaction
+ 1
Countries
+ 1
Approvals
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Intelligent Solutions

MSC MED stands out for its team with technical and scientific training to help your company prepare the best possible documentation, and thus obtain health records from Anvisa, FDA, CE Marking and other regulatory bodies.

In addition to managing the process before regulatory agencies, we can also develop or assist with evaluation, validation and supplementary documentation of safety and efficacy protocols for medical products.

Technical guidance for ANVISA, INMETRO, FDA and CE Marking

Planning, conducting and managing activities related to approval for commercialization by different regulatory agencies. When necessary, elaboration of test plans, definition of sampling and minimum performance criteria for the products, based on the conditions of clinical use of the product and on national and international regulations for proof of safety and efficacy.

Safety and Efficacy Analysis of Medical Devices

Performance reviews related to the product's ability to meet applicable requirements for its proper functioning and safety. It involves approaches for mechanical, physical-chemical, stability, biocompatibility, sterility, usability, clinical evaluation, among many others. See our full list of services for more details.

Stability (Shelf-Life)

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). 

MRI Environment Compatibility

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).

Company legalization

Technical guidance for obtaining a Sanitary License, Authorization to Operate a Company (AFE) and/or Certification of Good Manufacturing Practices (CBPF).

Clinical Evaluation

Conducting the collection, screening and analysis of clinical data referring to the use of medical technologies, in order to assess the safety and efficacy 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.

Biological Evaluation/ Biological Risk Assessment

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.

Risk Management, Audits, Manufacturing Process Validations and much more!

We have complete solutions for your business. For a complete list of solutions, click here. 

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We have proven success internationally in helping our clients navigate technical and regulatory issues to effectively and efficiently achieve their goals, passing on our knowledge along the way. Your contact is very important! Choose one of the contact methods below or fill in the fields that we will get back to you shortly.

+55 (48) 98445-2696
+55 (48) 99608-0064

msc@mscmed.com.br
comercial@mscmed.com.br 

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    msc@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, 14, 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