Why Integration Testing is Essential: The Rationale Against Big Bang Testing
Why Integration Testing is Essential: The Rationale Against Big Bang Testing In the development of medical devices and pharmaceutical software, […]
未分類
未分類
What is Traceability in the V-Model?
What is Traceability in the V-Model? The V-Model and Traceability: Effectiveness and Key Points for Implementation Are you familiar with
未分類
Hazard Source Separation in Software Design─Why Prioritizing Safety is Essential
Hazard Source Separation in Software Design─Why Prioritizing Safety is Essential Introduction When working as an engineer, the most paramount priority
未分類
Why Software Cannot Be Tested Exhaustively
Why Software Cannot Be Tested Exhaustively During software development, testing is typically conducted to verify that the developed product functions
未分類
Why Cleanroom Methods Are Critical in Software Development for Medical Devices
Why Cleanroom Methods Are Critical in Software Development for Medical Devices The True Value of Cleanroom Methodology: A Practical Approach
未分類
What is SOUP? – How to Handle Software of Unknown Provenance
What is SOUP? – How to Handle Software of Unknown Provenance Today’s theme is “SOUP.” It is certainly a unique
State of the art
Understanding State of the Art: The Latest Technology Standards
Understanding State of the Art: The Latest Technology Standards Definition and Essence of State of the Art The phrase “State
ISO-14971:2019, Risk Management
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
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”
