Solutions

Meet Our Solutions

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.

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.

Safety and Efficacy Analysis of Surgical Implants

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.

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 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.

Regulatory Affairs

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.

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).
 

Market Clearance for Medical Devices

Preparation of Technical Dossier for registration or notification of medical devices before the National Health Surveillance Agency (ANVISA), the FDA (Food and Drug Agency), or CE Marking. 

INMETRO Certification

Consultancy and management of product processes subject to compulsory certification before INMETRO, such as medical equipment, syringes, needles, gloves, among others.

Medical Software Market Clearance

Preparation of Technical Dossier for registration or notification of medical software.
 

Company legalization

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

Certification of Good Manufacturing Practices (CBPF) for international companies

Assistance in defining the need or not for GMP certification for international medical device manufacturers. Preparation of dossier for CBPF request before Anvisa. Conducting training audits at international manufacturers.

Validation of Manufacturing Processes

Planning, conducting and managing activities related to the validation of special processes, such as: cleaning, sterilization, additive manufacturing (3D printing), packaging, anodizing/passivation, injection, reprocessing of instruments, among others.
 

Risk Management (ISO 14971)

Guidance in conducting activities related to risk management of medical devices, including survey and analysis of risks related to product operation, adverse events, design, usability, among other sources of risk.
 
 

Records Hosting and Private Label

Bring your product to be hosted within our structure. Maintenance of records before Anvisa. Put your brand on your product.
 

Audits

Conducting audits focusing on quality management systems or specific projects.

Computational Biomechanics

Conducting computer simulations (Finite Element Analysis - FEA) of mechanical or biomechanical models with medical devices for development, design verification, concept validation, product comparison and analysis of potential design improvements and the impact of product design changes.
 

Complete Solutions

National and International Presence

We guide your path and carry out activities to obtain permission to sell medical products before Anvisa and international regulatory agencies.

Without MSC MED
With MSC MED

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.

Looking for a differentiated solution?

Get in touch, our team has the right solution for you!

Excellence and Pioneering

Proven success

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!

Our specialties

...and much more!

MSC MED

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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

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