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Presentations - Checklists - Guides -

 

HFES2023 - User Groups

Determining User Groups for Usability. Answering key questions:

Who exactly are my device users?
How do we determine who to test, while also ensuring accurate representation?

 

UNpacking HF

Overview of Human Factors principles, specifically to better understand how packaging and packaging systems are evaluated in usability studies.

HFES Presentation

User experience and human factors engineering (HFE) are both essential components to any product development life cycle. These two components have varying approaches, goals, and criterion for success. However, with a proper strategy in place, both human factors and user experience can be integrated to assess product usability.

 

HFES2023 - Scalable HF Strategies

Every medical device, drug, or combination product varies in user interface complexity, potential use risks, intended users and intended use cases. The user interface evaluation plan is scaled according to the variation in these factors.

EU MDR Checklist

In pursuit of EU MDR compliance, many organizations have begun to construct an EU MDR general safety and performance (GSPR) checklist. In short, this document outlines the exact procedures that the organization must follow to comply with these standards.

 

HFES Presentation

This presentation will dive into the capabilities and characteristics of digital device and cybersecurity product users as they relate to safe and effective device use. It will explore users, user groups, current recruiting and screening practices, and strategies to ensure compliance with FDA guidance for human factors testing.