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Physical-Real world testing - Clinical Investigation

Physical
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: 60459ffb-fc18-43af-a060-20694884a13b

Service Description

Clinical investigations involve rigorous testing of AI technologies or healthcare solutions in real-world clinical environments. The investigation involves one or more human subjects, and the goal is to assess the clinical performance, effectiveness or safety of a medical device. ULS Coimbra act as an Investigation site, providing: - Principal invistigatior qualified by education, training and experience - Trained research staff - Acess to specific patient population - Site facilities that comply with requeriments of intended use of device - Hospital Ethics Comittee submission - Site selection report documenting qualifications of the principal investigator and the suitability of the investigation site This service can be complemented with the support of CRO services.

Offerings: Expert Medical Opinion Testing Clinical (investigation, trial, etc.) Testing Facility Real-World (ER, OR, ICU, office, ambulance, ward, patient home, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)
Provider Country Portugal
Published Email tef-services@ulscoimbra.min-saude.pt

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs 1- Device description and general information. 2- Test reports (according to mandatory applicable standards) 3- raw material technical information (if applicable) 4- Risk report
Service Outputs 1- Clinical study Report 2- Clinical Investigation Report
Certification Support ISO 14155
  • ISO 14155

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