Innovating Works

HORIZON-HLTH-2024-IND-06-08

Cerrada

Temáticas obligatorias de los proyectos para la ayuda HORIZON-HLTH-2024-IND-06-08

Temática principal:
The project aims to enhance the regulatory environment for medical devices and IVDs, focusing on evidence generation and evaluation. It seeks to establish frameworks for clinical evidence requirements, develop methodological approaches, and utilize real-world data for compliance. The project will address gaps in evidence, bridge iterative device development, and integrate diverse data sources for comprehensive clinical evaluations. The project aims to enhance the regulatory environment for medical devices and IVDs, focusing on evidence generation and evaluation. It seeks to establish frameworks for clinical evidence requirements, develop methodological approaches, and utilize real-world data for compliance. The project will address gaps in evidence, bridge iterative device development, and integrate diverse data sources for comprehensive clinical evaluations.
Patient care
Health services
health care research
Integrated care
Health management systems
Registries
Preparedness
Risk assessment
Epidemiology
Comparative effectiveness research
Electronic patient files
Health policy and services
Privacy policies
Surveillance
Meta-analysis
Homecare
Early warning systems
Digital Agenda
Medical service
Clinical management
Healthcare system
Clinical trials
Medical devices
safety
performance
clinical evaluation
high-risk medical devices
evidence generation
life-cycle approach
clinical evidence
medical device software
AI enabled devices
next generation sequencing
innovative devices
market access
post-market surveillance
benefit-risk ratio
Health Technology Assessment
common specifications
standardised endpoints
health outcomes measures
device technologies
registries
real-world data
regulatory compliance
data quality
data reliability
statistical methods
data analysis
biases
data linkage
bridging studies
iterative development
data sources
national competent authorities
notified bodies
IVD laboratories
Health Technology Assessment bodies
clinical studies.
IVDs
Evidence generation
Clinical evidence
Real-world data
Compliance
Device development
Data sources
Clinical evaluations
Medical Devices Regulation
Clinical Evidence Generation
Real-world Data Integration
health care research
safety
performance
clinical evaluation
high-risk medical devices
evidence generation
life-cycle approach
clinical evidence
medical device software
AI enabled devices
next generation sequencing
innovative devices
market access
post-market surveillance
benefit-risk ratio
Health Technology Assessment
common specifications
standardised endpoints
health outcomes measures
device technologies
registries
real-world data
regulatory compliance
data quality
data reliability
statistical methods
data analysis
biases
data linkage
bridging studies
iterative development
data sources
national competent authorities
notified bodies
IVD laboratories
Health Technology Assessment bodies
clinical studies
Safety
Performance
Clinical evaluation
High-risk medical devices
Life-cycle approach
Medical device software
Next generation sequencing
Innovative devices
Market access
Post-market surveillance
Benefit-risk ratio
Common specifications
Standardised endpoints
Health outcomes measures
Device technologies
Regulatory compliance
Data quality
Data reliability
Statistical methods
Data analysis
Biases
Data linkage
Bridging studies
Iterative development
National competent authorities
Notified bodies
Clinical studies
Safety
Performance
Clinical evaluation
High-risk medical devices
Life-cycle approach
Medical device software
Next generation sequencing
Innovative devices
Market access
Post-market surveillance
Benefit-risk ratio
Common specifications
Standardised endpoints
Health outcomes measures
Device technologies
Regulatory compliance
Data quality
Data reliability
Statistical methods
Data analysis
Biases
Data linkage
Bridging studies
Iterative development
National competent authorities
Notified bodies
Clinical studies