Software Components VS. Independent Software - Regulatory News - Medical Devices

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

Type	Feature similarity	Feature 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	One or multiple medical usage	Medical device hardware is not necessary for completing the intended use of the software Operate on the general computing platform

Classification

Basic Type		Installation Type	Hardware Relationship	Main Function	Example
Software component	Embedded type	Medical device firmware	control	Operation (conduct)	Electro- cardiograph included software
Software component	Control type	General computer	control	Operation (conduct)	CT image collecting workstation software CT
Independent software	General type	General computer	~~--------------~~	conduct	Patient Physiological Monitor
Independent software	Exclusive type	Exclusive medical device	communicate	conduct	Holter 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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