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, Risk Management
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
ISO-14971:2019, Risk Management
Understanding Reasonably Foreseeable Misuse
Understanding Reasonably Foreseeable Misuse In the design of medical devices and industrial equipment, the concept of “reasonably foreseeable misuse” is
SaMD
What is SaMD – When Software Alone Becomes a Medical Device
What is SaMD – When Software Alone Becomes a Medical Device Smartphone applications support physician diagnoses, and game-like software is
IEC 62304
Why Verification Records Are Required for All Specifications
Why Verification Records Are Required for All Specifications In the development of medical device software, the IEC 62304 standard requires
ISO-14971:2019, Risk Management
Understanding Benefit-Risk Analysis
Understanding Benefit-Risk Analysis In the development of medical devices and pharmaceuticals, creating a “completely safe” product is realistically impossible. No
Design Control
Understanding Medical Device Families
Understanding Medical Device Families In the development and manufacturing of medical devices, the concept of “medical device family” plays an
ISO-14971:2019, Risk Management
Understanding the Risk Management File (RMF)
Understanding the Risk Management File (RMF) For a sample Risk Management File, please see here. In the development of medical
