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Usability: Summative evaluation of medical device

TEF-Health Service
Physical
Pricing/Discount Options: Call #2
Unique Identifier: a204b41f-054c-4cfb-a99c-d633a0929b48

Service Description

Overview

A summative evaluation is the final usability validation conducted to demonstrate that the intended users can use a medical device safely and effectively under the intended conditions of use. The use of the medical device by the intended users (healthcare professionals and/or patients) is evaluated by a usability specialist, preferably in the intended use environment. It includes:

  • Development of evaluation protocols tailored to the intended user profiles
  • Recruitment of required healthcare professionals and/or patients (if needed)
  • Rental of an operating room (if needed)
  • Rental of phantoms (physical test object that simulates human anatomy) (if needed)
  • One user testing step followed by result analysis
  • Evaluation report including usability findings, recommended design improvements, and guidelines for the medical device

How can the service help you?

According to IEC 62366-1, medical device manufacturers need to perform a summative evaluation of their medical devices. This activity should be documented in the Technical Documentation reviewed by notified bodies.

How will the service be delivered?

This service is led by a usability specialist in collaboration with healthcare professionals and/or patients. Typically, 10 participants are included. It can be conducted either at our facility with our healthcare professionals or at the manufacturer’s site with those of the manufacturer.

Technical details

Work Package 1 – Initial Scoping and Alignment Review of the existing medical device and its specific features, analysis of the available documentation (risk analysis, task analysis, use scenarios), hands-on review of the medical device/demo, and discussions with the product team. Identification of key user tasks and key usability challenges.

Work Package 2 – Summative Evaluation Implementation Definition of the summative evaluation plan (critical/key tasks) Recruitment of healthcare professionals and/or patients and preparation of the test room and logistics Conduct of user evaluation sessions and observation of user performance (interpretation of results, identification of inconsistencies, confidence in the system) Analysis of the results

Service customization

Recruitment of required healthcare professionals and/or patients, rental of an operating room and phantoms are optional. The summative evaluation should be conducted once the final product design has been completed.

Keywords: Usability summative evaluation
Service categories: Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.) Testing Facility Simulated (ER, OR, ICU, office, ambulance, ward, patient home, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Ask about this service
Billing: per evaluation
Full Price 8000–30000 EUR
Reduced Price 5000–25000 EUR
Pricing Detail

Prices are subject to change and are indicative only. The final price will be determined by a quote based on SME's needs, and it wil be validated by the contract between the service provider and the applicant.

Operational Details

Service Inputs Product intended use, product risk analysis
Service Outputs Evaluation report including usability findings, recommended design improvements, and guidelines for the medical device
Service Standards
  • IEC 62366-1

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