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Usability consulting for medical devices

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 192ee915-f105-4353-a5ea-3e77a26744e6

Service Description

Support iterative process of usability of the medical device prototype for CE mark. Includes the definition/revision of inputs for the usability specification according to the available documentation: - the intended use of the medical device - the risk analysis linked to usability - use scenarios Depending the SME needs, this service may be: - an expert evaluation by an ergonomist or; - support on protocol writing for formative evaluation.

The proposed method is based on a user-centered procedure, as described in ISO 9241-210 on the ergonomics of human-system interaction, and complies with ISO 62366-1/ ISO 62366-2 on the usability of medical devices.

Keywords: Usability test, Formative evaluation, Summative evaluation

Offerings: 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
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Provider & Contact

Provider Country France
Published Email tef-health@chu-grenoble.fr

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 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
  • IEC 62366-1