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Medical Devices Notified Body (MDS ON-PT)
Líder
Aveiro University
Parceiros Institucionais

ANTRAM - Associação Nacional de Transportadores Públicos Rodoviários de Mercadorias; IT- Instituto de Telecomunicações; Inova-ria- Associação de Empresas para uma Rede de Inovação em Aveiro.

Consultar enquadramento do projeto: aqui.

Valor Total do Projeto
1.365.411,07 €
Financiamento Total
85%
Duração
36 meses (1/12/2025 -30/11/2028)
Barra de Logos_C2030_PT2030_UE
Estado
Aberto
ON_New_DB
soon available
Descrição

The Medical Devices Notified Body (MDS ON-PT) project aims to establish the conditions for the creation of a Notified Body dedicated to the conformity assessment and certification of technology-based medical devices in Portugal. Led by a consortium comprising INOVA-RIA, the University of Aveiro, the University of Beira Interior, the University of Coimbra and the Portugal Digital Technology for Health Association (PDTH), the project seeks to strengthen the Centro Region's innovation ecosystem by fostering knowledge transfer, regulatory capacity and collaboration between academia, healthcare institutions and industry.

Through specialised training, the development of a quality management system, international networking and stakeholder engagement, the project will build the technical, organisational and human capacities required to support the certification of innovative medical devices. Ultimately, it aims to accelerate the market access of health technologies, enhance the competitiveness of Portuguese companies and position the Centro Region as a reference hub for digital and technology-based medical devices.

Objetivos
  • Establish the foundations for a Notified Body specialised in technology-based medical devices.
  • Develop the technical, organisational and regulatory capacities required for conformity assessment and certification.
  • Train specialised human resources in medical device regulation and quality assurance.
  • Foster collaboration between universities, research organisations, healthcare providers and industry.
  • Promote knowledge transfer and innovation within the regional health technology ecosystem.
  • Increase the international competitiveness of Portuguese medical device companies by facilitating access to European and global markets.
  • Position the Centro Region as a leading innovation hub for digital health and technology-based medical devices.


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