Why Focus on Residual Risk Rather Than Initial Risk?
Why Focus on Residual Risk Rather Than Initial Risk? Shifting Focus from Initial Risk to Residual Risk — Why Should […]
ISO-14971:2019, Risk Management
Risk
ISO-14971:2019, Risk Management
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
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”
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
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
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
