Why Focus on the Probability of Harm Rather Than the Probability of Defects?
Understanding Reasonably Foreseeable Misuse
What is SaMD – When Software Alone Becomes a Medical Device
Why Verification Records Are Required for All Specifications
Understanding Benefit-Risk Analysis
Understanding Medical Device Families
Understanding the Risk Management File (RMF)
Why We Reduce Probability Rather Than Severity: The Fundamental Logic of Risk Control