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Physical-Real world testing- Usability testing- Summative testing

Physical
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: d5e7a4ef-077b-4b7b-a44d-4f19e8016244

Service Description

Summative usability testing assesses the final product’s usability and compliance with regulatory standards. The main objective is to evaluate the overall usability performance of the device, and not necessarily to identify specific problems to be corrected. This service ensures that the technology meets the needs of end-users, and aligns with clinical workflows.This packaged service can include: - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate

Offerings: Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.) 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- Existing test reports (according to mandatory applicable standards) 3- raw material technical information (if applicable)
Service Outputs 1- Usability Report
Certification Support ISO/IEC 62366
  • ISO/IEC 62366

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