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Usability: consulting for medical devices

TEF-Health Service
Physical Consulting Virtual
Pricing/Discount Options: Call #2
Unique Identifier: 192ee915-f105-4353-a5ea-3e77a26744e6

Service Description

Overview

This service provides to the SME support by usability specialist for formative and/or summative evaluations of the medical device. Depending the SME needs, this may be either an expert evaluation or support on protocol writing. It includes the definition or revision of the inputs to the usability specification, based on the available documentation: the intended use of the medical device, the risk analysis linked to usability and use scenarios.

How can the service help you?

According to IEC 62366-1, medical device manufacturers need to perform formative and summative evaluations 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 can be led remotely.

Technical details

The details of the service will depend on SME needs.

Keywords: Usability formative evaluation summative evaluation
Service categories: Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.) Testing Conformity & Compliance Software (security, privacy, usability, accountability, fairness, reliability, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Organisation Website https://www.chu-grenoble.fr/
Ask about this service
Billing: per hour
Full Price 80–150 EUR
Reduced Price 35–135 EUR
Pricing Detail

Prices are subject to change and are indicative only. The final price will be determined in the contract between the service provider and the applicant

Operational Details

Service Inputs Depending the maturity level of the solution and the available documentation: - Intended use of the medical device - Risk analysis of the medical device - Technical specifications - User manual of the medical device
Service Outputs Report
Service Standards
  • IEC 62366-1

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