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
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
usability
Why Class I Medical Devices Are Subject to Usability Engineering
Why Class I Medical Devices Are Subject to Usability Engineering Examining Why Class I Medical Devices Are Subject to Usability
ISO-14971:2019, Risk Management, Risk Management
Understanding the Difference Between Risks and Issues
Understanding the Difference Between Risks and Issues In business and daily life, the terms “risk” and “issue” are frequently used.
ISO-14971:2019, Risk Management
What is Safety? Why Zero Risk Does Not Exist
What is Safety? Why Zero Risk Does Not Exist “This product is safe.” “We provide a safe environment.” We hear
ISO-14971:2019, Risk Management
Understanding the Three-Step Method
Understanding the Three-Step Method Ensuring product safety is one of the most critical responsibilities for manufacturers. However, every product inherently
ISO-14971:2019, Risk Management
Why Focus on the Probability of Harm Rather Than the Probability of Defects?
Why Focus on the Probability of Harm Rather Than the Probability of Defects? In medical device risk management, risk is
