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Usability Testing Implementation (IEC 62366-1:2015)

Consulting
Pricing/Discount Options: Call #2 Call #1
Unique Identifier: d1793fe3-0b46-4535-af53-ca702136c5fe

Service Description

User interface evaluation is conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors. The usability testing focuses on the user experience with the device, including the device's graphical user interface (GUI). While a formative usability test goal is to identify and correct any usability problems before the device design is finalized, a summative usability testing intends to generate evidence that a final product that is not only functional but also intuitive and enjoyable to use, leading to increased user satisfaction and loyalty. IPN is able to provide support in a two-step approach: • Study Documents & Submission Process, supporting the preparation of the mandatory documents and the submission of study to the Regulatory Authorities (ethics committees); • Study Conduction & Data Management, supporting the Site Initiation activities, recruitment process, data collection/analysis according to good clinical practices and report

Keywords: Usability formative summative
Offerings: Ethics & Regulatory Affairs Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Testing Conformity & Compliance Hardware (CE, MDR, usability, etc.) Testing Clinical (investigation, trial, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)
Provider Country Portugal
Published Email medicaldevices@ipn.pt

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Operational Details

Certification Support CE Marking (MDR, IVDR)
  • CE Marking
Service Standards
  • ISO/IEC 62366
  • MDR EU 2017/745

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