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Software Components VS. Independent Software

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Medical device software includes software components and independent software. Their management type, registration test and clinical evaluation are all different in the CFDA registration. It is really important for the manufacturer to distinguish the difference between software components and independent software.

Definitions of software components and independent software
Software components ---- the software in medical device or the component of medical device. It can be medical device or medical device software components or attachment.
Independent software--- the software itself is managed as a medical device. It can be used as medical device or medical device software attachment.

Software Components Features VS. Independ Software Features

TypeFeature similarityFeature difference
software components






One or multiple medical usage
  • Control the hardware of the medical devices or operate on the dedicated medical computing platform
independent software
  • Medical device hardware is not necessary for completing the intended use of the software
  • Operate on the general computing platform


Classification

Basic TypeInstallation TypeHardware RelationshipMain
Function
Example
Software
component
Embedded typeMedical device firmwarecontrolOperation
(conduct)
Electro-
cardiograph included software
Control
type
General computercontrolOperation
(conduct)
CT image collecting workstation software CT
Independent
software
General
type
General computer--------------conductPatient Physiological Monitor
Exclusive
type
Exclusive medical devicecommunicateconductHolter data analysis software
  • Embedded software (firmwave) operates on the dedicated medical computing platform. It can control (driver) the hardware of the medical devices.
  • Control type software operates on the general computing platform. Control( driver)the hardware of the medical devices
  • General type software is connecting through the general data interface, to combined utilization with multiple medical device general
  • Exclusive type software is connecting through general or dedicated data interface, to combined utilization with specific medical device.

  

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