Reasonably Foreseeable Misuse in Medical Device Design
Reasonably Foreseeable Misuse in Medical Device Design Learning from Errors and Clarifying Responsibility Introduction When designing a new product, designers […]
Risk Management
usability
Understanding the Difference Between Formative and Summative Assessment
Understanding the Difference Between Formative and Summative Assessment Introduction to Formative and Summative Assessment Formative assessment and summative assessment are
usability
Task Analysis: A Practical Approach in Medical Device Development
Task Analysis: A Practical Approach in Medical Device Development Examining “Task Analysis” Through the Example of Blood Pressure Measurement Introduction
Risk Management, usability
Why Integrate Risk Management and Usability Engineering?
Why Integrate Risk Management and Usability Engineering? The Growing Importance of Risk Management and Usability Engineering in Medical Device Development
usability
Tailoring: What It Means
Tailoring: What It Means Tailoring and the Art of Usability Engineering: Haute Couture in the Medical Device Industry What does
usability
What is UOUP? A Professional Explanation for the Medical Device Industry
What is UOUP? A Professional Explanation for the Medical Device Industry Introduction In medical device development, responsibility for user interfaces
usability
IEC 62366-1 and IEC 62366-2: Understanding the Distinction
IEC 62366-1 and IEC 62366-2: Understanding the Distinction Clarifying the Divide Between IEC 62366-1 and IEC 62366-2 Usability engineering in
Standard
Why International Standards Don’t Explicitly Specify “How”
Why International Standards Don’t Explicitly Specify “How” Introduction For companies worldwide to guarantee the quality of products and services and
usability
Why the FDA Standardized the Term “Human Factors Engineering”: Understanding Terminology, Regulatory Expectations, and Current Trends
Why the FDA Standardized the Term “Human Factors Engineering”: Understanding Terminology, Regulatory Expectations, and Current Trends FDA and Usability: Terminology
Presubmission
Why Presubmission is Important
Why Presubmission is Important Optimizing Regulatory Strategy through Collaboration with Regulatory Authorities Have you heard the term “presubmission”? This concept
