Performance Evaluation

Usability Studies for IVD Manufacturers

Navigating the intricacies of In Vitro Diagnostic Regulation (IVDR) requires a meticulous approach. For IVD manufacturers, user-centric testing and usability studies are paramount in ensuring regulatory compliance. We empower manufacturers to enhance the user experience, accelerate their CE marking process, and smoothly transition into the new regulatory landscape.



Importance and Understanding Usability Studies

Usability studies involve a comprehensive evaluation process that focuses on the user experience, ease of use, and effectiveness of in vitro diagnostic medical devices. In the context of IVDR, they hold immense importance:

  • IVDR Guidelines: Usability studies are aligned with IVDR guidelines, ensuring that devices meet the highest regulatory standards.

  • User-Centric Approach: We prioritise lay-person users, addressing their needs and diverse behaviours, to minimize usability issues.

  • Transitional Period: Usability studies aid manufacturers in navigating the transitional period, making the shift from previous regulations to IVDR smoother.

  • CE Marking: User-centric testing accelerates the CE marking process, ensuring quicker market entry for IVD medical devices.


Our Process

  • Define Objectives and Scope

  • User Profiling: (Lay-person healthcare professional)

  • Patient Recruitment

  • Usability Testing

  • Data Collection & Analysis

  • Report & Findings


How PeploBio Empowers IVD Manufacturers

At PeploBio, we empower IVD manufacturers through a systematic approach to usability studies:

  • Types of Usability Testing

    Types of Usability Testing: We conduct various types of usability testing, including remote usability testing, to address specific device requirements.

  • Real Users, Real Experiences

    Real Users, Real Experiences: Our studies involve real users, not just professionals, to ensure that the device performs as intended in the hands of lay-person users.

  • Development Process

    Usability testing is integrated into the device development process, preventing usability issues from arising at later stages.

  • Risk Class Expertise

    We understand the implications of risk class on usability, ensuring devices meet the safety and performance expectations of the intended users.


Why Choose PeploBio

Choosing PeploBio for usability studies offers a range of benefits:

  • Expert Test Participants

    Our usability studies involve test participants with diverse backgrounds to ensure comprehensive feedback.

  • User Behavior Insights

    We delve deep into user behavior to identify potential issues and areas for improvement.

  • Actionable Test Results

    Our testing delivers actionable insights, enabling manufacturers to make data-driven design enhancements.

Contact us to find out more

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