• Tejaswi P. Alekya
  • M.P. Venkatesh
  • Pramod Kumar T.M.


The use of software in a medical device allows the manufacturer to concentrate on the application needed to run device-specific functions. The medical device manufacturer using software generally neglect software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device. Software created for medical purposes and non-medical purpose is being used in healthcare. Earlier, hardware was more important; but in the recent times software one of the element for overall implementation has surpassed the prominence than hardware. Software is vital for the design, architecture and functionally of medical devices. Regulatory bodies have taken approaches in developing definitions and frameworks for software that have common public health goals, with variations in approach. Regulatory guidelines from such regulatory bodies for medical software established and implemented, serves as an environmental scan to provide direction on the guidelines on proposed regulatory framework for adoption, based on best practices. Medical software regulation is aimed to facilitate member economies to establish and harmonize an economic and effective approach for control of medical software in the interest of public health, in the continued innovation of medical software development.

Keywords: Software, Regulatory bodies, Medical device and Hardware.


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How to Cite
Alekya, T. P., M. Venkatesh, and P. K. T.M. “SOFTWARE AS MEDICAL DEVICE”. International Journal of Drug Regulatory Affairs, Vol. 4, no. 2, Feb. 2018, pp. 10-18, doi:10.22270/ijdra.v4i2.181.