Understanding Reasonably Foreseeable Misuse
Understanding Reasonably Foreseeable Misuse In the design of medical devices and industrial equipment, the concept of “reasonably foreseeable misuse” is […]
ISO-14971:2019, Risk Management
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
ISO-14971:2019, Risk Management
Why We Reduce Probability Rather Than Severity: The Fundamental Logic of Risk Control
Why We Reduce Probability Rather Than Severity: The Fundamental Logic of Risk Control Anyone working in the field of risk
IVD
What Are the Unique Characteristics of the Risk Model for In Vitro Diagnostic Medical Devices (IVDs)?
What Are the Unique Characteristics of the Risk Model for In Vitro Diagnostic Medical Devices (IVDs)? When people hear the
usability
Understanding the Difference Between Use Error and Misuse
Understanding the Difference Between Use Error and Misuse In the development of medical devices and industrial equipment, the terms “use
ISO-14971:2019, Risk Management
Why FMEA Should Not Be Used for Medical Device Design
Why FMEA Should Not Be Used for Medical Device Design Introduction Risk management is the most critical process for ensuring
