Why Integrate Risk Management and Usability Engineering?
Tailoring: What It Means
What is UOUP? A Professional Explanation for the Medical Device Industry
IEC 62366-1 and IEC 62366-2: Understanding the Distinction
Why International Standards Don’t Explicitly Specify “How”
Why the FDA Standardized the Term “Human Factors Engineering”: Understanding Terminology, Regulatory Expectations, and Current Trends
Why Class I Medical Devices Are Subject to Usability Engineering
Understanding the Difference Between Risks and Issues