What is DTx (Digital Therapeutics)?
What is DTx (Digital Therapeutics)? DTx (Digital Therapeutics): A New Paradigm in Software-Driven Healthcare Digital technology has become pervasive in […]
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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,
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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
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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
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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
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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
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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
