Understanding the 3 Step Method
Understanding the 3 Step Method A Comprehensive Risk Control Approach for Beginners Modern organizations, particularly those in industries handling medical […]
Risk Management
Competence
Why Competent Personnel Are Essential
Why Competent Personnel Are Essential The Necessity of “Competence”—Examining through the Lens of Driving License Acquisition When we learn something
usability
The Importance of Usability: Lessons from Aviation Accidents
The Importance of Usability: Lessons from Aviation Accidents Pursuing the latest technology and optimizing performance is undoubtedly important. However, equally
usability
What is a Usability Engineering File?
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
Usability Considerations Throughout the Lifecycle of Medical Devices Unlocking the True Value of Medical Devices: The Importance of Usability Considerations
Why Usability Engineering Is Necessary for Non-Software Medical Devices
Why Usability Engineering Is Necessary for Non-Software Medical Devices The Importance of Usability Engineering in Non-Software Medical Devices The concept
未分類
Responding to Affidavit Requests During FDA Inspections
When introducing pharmaceuticals or medical devices to the U.S. market, inspections by the Food and Drug Administration (FDA) represent a
未分類
Breaking News: FDA Issues CSA Guidance
On September 24, 2025, the U.S. Food and Drug Administration (FDA) officially issued guidance of critical importance to the medical
未分類
What Makes a Company Trustworthy in the Eyes of the FDA
The New Wave of Quality Management Regulatory and quality management practices in the medical device and pharmaceutical industries continue to
未分類
A $30 Monthly AI Investment: A Challenge for Personal Growth
In 2025, our work styles are changing quietly yet decisively. We are moving from “using AI” to “collaborating with AI.”
