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 FDA, CE Mark, ANVISA. Leave the Technical File with us. We can help you with your clinical evaluation and your pre-clinical evaluation (project verification). We count on an international network of accredited laboratories and may find you the best deal.

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We are a CRO specialized in Medical Devices. We perform clinical investigations/trials from protocol to data collection, considering all regulatory approvals and ethical aspects.

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Count on our hosting and representation services for Brazil, USA and South America.

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Count on our medical engineering team to help you with testing plans and computational tools (Finite Element Analysis). We can help you with mechanical testing, biologic testing, stability testing, MRI compatibility...

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MSC MED combines scientific expertise with extensive knowledge of the international regulatory framework, offering methodologies to aid in the development of design for implantable medical devices, guaranteeing the end user of the product the necessary safety and effectiveness. We can help you with medical product evaluation and to obtain clearances in agencies such as ANVISA, FDA, Health Canada, TGA and CE Mark. We are also an experienced CRO, able to conduct your medical device clinical investigation.

[/zozo_vc_section_title][vc_empty_space height=”22px”][vc_empty_space height=”22px”][vc_row_inner][vc_column_inner css=”.vc_custom_1502351274557{padding-bottom: 75px !important;}” offset=”vc_col-lg-4 vc_col-md-12″][zozo_vc_feature_box box_style=”info-box” info_box_style=”box-without-bg” text_align=”center” type=”fontawesome” icon_fontawesome=”fa fa-pencil” icon_size=”exlarge” icon_hover_style=”icon-hv-color” title=”Orientação técnica para registro ANVISA, FDA e CE” title_type=”h4″ separator=”no” button_url=”url:%23||” icon_icomoonpack2=”icomoon2 icomoon2-heart4″ button_text=”Saiba Mais” css=”.vc_custom_1504903668990{margin-bottom: 25px !important;border-bottom-width: 1px !important;padding-bottom: 25px !important;border-bottom-color: #e1e1e1 !important;border-bottom-style: solid !important;}”]Seleção de ensaios e elaboração de documentação técnica adequada a cada agência reguladora.[/zozo_vc_feature_box][vc_empty_space height=”22px”][zozo_vc_feature_box box_style=”title-top-icon” text_align=”center” type=”fontawesome” icon_fontawesome=”fa fa-check-circle” icon_size=”exlarge” icon_hover_style=”icon-hv-color” title=”Análise de Segurança e Eficácia de implantes cirúrgicos” title_type=”h4″ separator=”no” button_url=”url:%23||” icon_icomoonpack1=”icomoon1 icomoon-eye-plus” button_text=”Saiba Mais”]Utilização de métodos analíticos e numéricos para a definição do caso crítico para uma gama de produtos. Comparação dos resultados dos ensaios com critérios de desempenho biomecânico derivado de pesquisas científicas.[/zozo_vc_feature_box][/vc_column_inner][vc_column_inner el_class=”center-full-image-top” offset=”vc_col-lg-4 vc_col-md-12″ css=”.vc_custom_1502352337522{padding-bottom: -75px !important;}”][vc_single_image image=”11658″ img_size=”full” alignment=”center”][/vc_column_inner][vc_column_inner css=”.vc_custom_1502351299470{padding-bottom: 75px !important;}” offset=”vc_col-lg-4 vc_col-md-12″][zozo_vc_feature_box box_style=”title-top-icon” text_align=”center” type=”fontawesome” icon_fontawesome=”fa fa-desktop” icon_size=”exlarge” icon_hover_style=”icon-hv-color” title=”Simulação computacional de sistemas biomecânicos” title_type=”h4″ separator=”no” button_url=”url:%23||” icon_icomoonpack2=”icomoon2 icomoon2-heart4″ button_text=”Saiba Mais” css=”.vc_custom_1504903692682{margin-bottom: 25px !important;border-bottom-width: 1px !important;padding-bottom: 25px !important;border-bottom-color: #e1e1e1 !important;border-bottom-style: solid !important;}”]Análise numérica simulando a condição de demanda mecânica in vivo para inferir o desempenho biomecânico do produto sob carregamentos quasi-estático e/ou sob cargas cíclicas.[/zozo_vc_feature_box][vc_empty_space height=”22px”][zozo_vc_feature_box box_style=”title-top-icon” text_align=”center” type=”fontawesome” icon_fontawesome=”fa fa-medkit” icon_size=”exlarge” icon_hover_style=”icon-hv-color” title=”Avaliação Clínica e Investigação Clínica” title_type=”h4″ separator=”no” button_url=”url:%23||” icon_icomoonpack1=”icomoon1 icomoon-eye-plus” button_text=”Saiba Mais”]

Conducting clinical studies through literature databases. Design of retrospective and prospective studies, prospecting of data collection centers, management of clinical investigation. Post-Market Follow-Up Plans (PMCF)

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+55 (48) 99608-0064

Escritório Comercial e Hospedagem: Av. Paraná, 1755, Conj. 96 - Boa Vista. Curitiba/PR

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