Why Objective Evidence Matters: Performance Evaluation and Regulatory Requirements in Medical Devices Introduction In today’s business landscape, particularly within the […]
Medical Devices Where Training Becomes an Approval Requirement Introduction: The Hidden Elite of Medical Devices What comes to mind when
Why Should We Focus on Differences from Predicated Devices in Medical Device Design? A Lesson from Design Change Implementation In
Why Consideration of the Use Environment is Critical Environmental Factors and Their Impact on Safety—Key Points to Understand for Effective
Why User Profile Identification is Important A Message to Those in the Design Field: The Importance of User Profile Identification
Understanding the 3 Step Method A Comprehensive Risk Control Approach for Beginners Modern organizations, particularly those in industries handling medical
Why Competent Personnel Are Essential The Necessity of “Competence”—Examining through the Lens of Driving License Acquisition When we learn something
The Importance of Usability: Lessons from Aviation Accidents Pursuing the latest technology and optimizing performance is undoubtedly important. However, equally
What is a Usability Engineering File? The term “Usability Engineering File” (UEF) may sound unfamiliar to many people. To understand
Usability Considerations Throughout the Lifecycle of Medical Devices Unlocking the True Value of Medical Devices: The Importance of Usability Considerations
