Advanced manufacturing, smart textiles and digitalisation
STUDY OF THE IMPLEMENTATION OF CLINICAL RESEARCH PLANS TO BOOST IMPROVEMENTS IN QUALITY OF LIFE
CLINIC-PLAN
Motivations
The field of medical devices is continuously developing and innovation in this sector is progressing exponentially and the new European Regulation (EU) 2017/745 responds to a widespread concern about the safety of medical devices.
This new piece of legislation incorporates stricter requirements for medical devices with regard to clinical research, which are deemed necessary for the certification of new products, sometimes after they have become commercially available.
AITEX has know-how in post-market clinical research and seeks to provide a service to the private sector, when there is a need for research to obtain CE marking for a new product.
The main motivation of the CLINIC_PLAN project is to acquire knowledge in the design and development of clinical research in order to offer a genuine service to meet the demand for medical devices, covering both pre-market (prior to certification) and post-market (after certification) needs.
Objectives
To provide the private sector with solutions via the transfer of the advances made by AITEX in clinical research on medical devices which require study before they are made commercially available, and as post-marketing follow-up.
The specific objectives are:
– Acquire knowledge of the regulatory management of clinical investigation according to the classification of the medical device.
– To achieve the ability to develop the different phases of a clinical investigation depending on the type of medical device involved where parameters such as experimental design, management and monitoring guidelines, statistical data processing and pharmacovigilance are required.
Value and competitive advantage
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Provide technical and professional advisory services to companies seeking support in the consulting and technical development of clinical research for medical products.
Results obtained
Definition of the design and development of clinical research to provide a genuine service to meet the market demand for medical products (MP):
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Updating regulations.
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Development of the methodologies and procedures necessary for conducting clinical research.
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Practical cases of potential clinical research studies.
Grant number: IMAMCA/2023/6
Programme: Plan of non-economic activities 2023
Period of execution: January 2023 – December 2023
Status: Finished
More information: PLAN OF ACTION
Entity: IVACE
This project is funded by the Conselleria d’Economia Sostenible, Sectors Productius, Comerç i Treball de la Generalitat Valenciana, through IVACE.
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ÁREAS DE I+D
Nuevos materiales de altas prestaciones y funcionalizados
Economía circular y sostenibilidad
Fabricación avanzada, textiles inteligentes y digitalización
Soluciones de alto valor añadido para mercados estratégicos
PROYECTOS RELACIONADOS
NOTICIAS
SAVE THE DATE! AITEX will host the 19th Textile ETP Annual Conference next year, from 13 to 14 May 2024 in AITEX headquarters, in Alcoy Alicante.
AITEX has attended the Cosmetorium fair in Barcelona once again on October to present its new products for the cosmetic sector.
AITEX analyses the problem of PFAS substances in various industrial sectors and presents various innovations to mitigate their presence in products and processes.
