Why Class I Medical Devices Are Subject to Usability Engineering
Understanding the Difference Between Risks and Issues
What is Safety? Why Zero Risk Does Not Exist
Understanding the Three-Step Method
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