NTT DATA Portugal

Support in Post-Market Surveillance (PMS)

Support in Post-Market Surveillance (PMS)

Apoio na Vigilância Pós-Mercado (PMS)

Support in Post-Market Surveillance (PMS)

Internal Audit (ISO 13485:2016, RDM) - specializing in Medical Device Software

Internal Audit (ISO 13485:2016, RDM) - specializing in Medical Device Software

Auditoria Interna (ISO 13485:2016, RDM) - especializada em Software de Dispositivos Médicos

Internal Audit (ISO 13485:2016, RDM) - specializing in Medical Device Software

How to maintain the QMS after certification

How to maintain the QMS after certification

Como manter o SGQ após a certificação

How to maintain the QMS after certification

Medical device risk management (ISO 14971:2019)

Medical device risk management (ISO 14971:2019)

Gestão de risco de dispositivos médicos (ISO 14971:2019)

Medical device risk management (ISO 14971:2019)

Support for MDR submissions: Technical documentation and QMS ready for audit.

Support for MDR submissions: Technical documentation and QMS ready for audit.

Suporte a submissões de MDR: Documentação técnica e SGQ pronto para auditoria

Support for MDR submissions: Technical documentation and QMS ready for audit.

Support/implementation of Quality Management System (ISO 13485:2016) - specialized in Medical Device Software

Support/implementation of Quality Management System (ISO 13485:2016) - specialized in Medical Device Software

Suporte/implementação de Sistema de Gestão da Qualidade (ISO 13485:2016) - especializado em Software de Dispositivos Médicos

Support/implementation of Quality Management System (ISO 13485:2016) - specialized in Medical Device Software

Tilt Table

Conducting usability tests and functional evaluations of the performance of developed products according to their intended use, comfort principles, and purpose.

Services for defining and implementing teams and governance models for clinical research centers.

Support services for defining the strategic plan of the clinical research center.

Services for defining and implementing procedures and models to support the financial management of clinical trials.

Services for defining and implementing teams and governance models for clinical research centers.

Services for the preparation and execution of training activities related to clinical trials.

Services for defining and implementing procedures and models to support the financial management of clinical trials.

Services for defining strategy, processes, and procedures for managing participants in clinical trials.

Services for the preparation and execution of training activities related to clinical trials.

Pre-compliance of hardware solutions for healthcare solutions

Support for the development of hardware for medical devices, with pre-conformity assessment in accordance with the standards and regulations applicable to the product.

Ideação de soluções e preparação de provas de conceito tecnológicas no âmbito dos ensaios clínicos

Level 1 sleep laboratory service, supporting studies and clinical trials by offering detailed and accurate analyses of sleep conditions, essential for research into sleep disorders and related treatments.

Numerical simulation

Numerical simulation studies (e.g., thermal, electrical, mechanical, electromagnetic, optical, fluidic) for performance evaluation and solution optimization.

Serviços de preparação e execução de ações de formação relacionadas com os ensaios clínicos

Services for defining strategy, processes, and procedures for managing participants in clinical trials.

Support for data management and analysis for clinical trials and studies.

Support in designing case report forms, managing databases, collecting clinical data, and performing statistical analysis.

Serviços para definição de estratégia, processos e procedimentos para gestão de participantes em ensaios clínicos

Numerical simulation studies (e.g., thermal, electrical, mechanical, electromagnetic, optical, fluidic) for performance evaluation and solution optimization.