What is a Risk Management File?
What is a Risk Management File? An Engineer’s Perspective As an engineer developing new medical devices, product safety is one […]
ISO-14971:2019, Risk Management
Risk Management
Why We Do Not Seek Probability Estimates for Human Errors and Software Errors
Why We Do Not Seek Probability Estimates for Human Errors and Software Errors Human Errors and Software Errors: Not “Eventually”
usability
Use Error and Human Error: Understanding the Critical Distinction
Use Error and Human Error: Understanding the Critical Distinction Introduction: Deep Understanding of Use Error and Human Error Is it
usability
Usability is NOT “Ease of Use”
Usability is NOT “Ease of Use” Do most people truly understand what “usability” means? In common parlance, it is often
Risk Management
Where Is the Boundary Between Normal Use and Abnormal Use?
Where Is the Boundary Between Normal Use and Abnormal Use? Defining Normal Use and Abnormal Use—Understanding Instructions to Prevent Problems
Risk Management
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
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
