SOFTWARE AS MEDICAL DEVICE
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 2
Abstract
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.
Authors and Affiliations
Alekya Tejaswi P, Venkatesh M P, Pramod Kumar T M
Keywords
Related Articles
- EP ID EP338052
- DOI -
- Views 109
- Downloads 0
QUALITY STANDARDS FOR MEDICAL DEVICES
Formerly with more augmented disabilities, Medical devices have become decisive device in many circumstances. As these are more perilous, the manufacturer should endow with an ideal medical device in aspects of safety &...
SUPAC OF IMMEDIATE-RELEASE, MODIFIED- RELEASE AND SEMI-SOLID: A REGULATORY NOTE
In today scenario, as per market demand there is definitely carry out an increment or decrease in production, this is called SUPAC. Different guidelines are provided for those different types of SUPAC in by different reg...
AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW
The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health...
INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION
ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respe...
DIRECTION TO REACH CLOSER TO THE EFFECTIVE LABELING OF DRUGS WITH CRITICAL PARAMETERS
Labeling of drugs is an art of expressing information, instructions, caution or warning etc. in both word and pictorial form which must be readable without magnifying glass or visualizing aids. Font size and background o...