Total Budget € 4.639.549 
Start date 17.02.2023
End date 17.02.2026
Website https://nobocap.eu/

Funding programme:

  • EU4Health

Partners:

ROHEALTH – The Health and Bioeconomy Cluster (Romania), coordinator – a cluster with members in the field of bioeconomy and health with extensive experience in research and development

 

  • SGS BELGIUM NV (Belgium) – multinational company, which provides inspection, verification, testing and certification services.
  • SGS IRELAND LIMITED (Ireland) – multinational company.
  • TECHNOLOGICAL UNIVERSITY DUBLIN (Ireland) – university.
  • UNIVERSITEIT GENT (Belgium) – university.
  • UAB DE FUTURO/iVITA (Lithuania) – health echnology cluster.
  • HBIO (Greece) – biosciences cluster.
  • ALTFACTOR (Romania) – software company.
  • EU4HEALTHSOLUTIONS (Belgium) – company.
  • MEDVIA (Belgium) – innovation cluster.
  • George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures – university.

About the project

The aim of the project is to increase the capacity of both notified bodies, conformity assessment bodies and market operators in the medical devices industry, particularly in the context of Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation to secure pathways for innovation in Europe.

More information

The NoBoCap project is a groundbreaking initiative under the wings of the EU4Health Programme, committed to fostering a conducive environment for swift and efficient advancement in the Medical Technology (MedTech) sector.

NoBoCap stands for the healthcare ecosystem and the medical device community in Europe, requiring a professional and fast processing of accreditation requests. The project will improve the medical device industry, by creating a matchmaking platform that allows for real‐time communication and collaboration between notified bodies and market operators.

Project objectives:  incorporating the main stakeholders of the industry while at the same time considering the high levels of impartiality, ensuring short- and long-term training goals for participants, evaluating present and forecasted market needs, and all this for both MDR and IVDR (in vitro diagnostic medical devices).

Respectively these initiatives project will improve technical knowledge at the NBs allowing new technologies to be adapted quickly with fewer delays in the approval process and will ensure that there is greater opportunity and visibility for a career path for staff to transit from industry to NBs, providing strong professional pathways for industry candidates to meet the entry requirements for NB’s.

This will result in industry and NB reducing time on technical and clinical assessments and NBs can stay ahead of the curve when it comes to a pipeline of human resources.

The project will have a great impact on NBs, CABs, market operators, healthcare professionals, and their patients in a sustainable and controlled manner.

Who is the receiver? Notified bodies and Conformity Assessment bodies, training partners, Innovators / Market Operators, Industry Associations and their Partners, (Biomedical) Engineering community, Patients, Hospitals, healthcare practitioners and patients

Contact

nobocap@rohealth.ro

 

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.