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 101
- Downloads 0
FORMULATION AND EVALUATION OF SOLID DISPERSION OF TADALAFIL
Tadalafil is used for the treatment of the erectile dysfunction (ED) and pulmonary arterial hypertension. It is having low aqueous solubility thus it shows poor bioavailability of about 28% by after oral administration....
REGULATORY ENVIRONMENT FOR MEDICAL DEVICES IN NEW ZEALAND
Medical Devices are one of the most important health intervention tools available for the prevention, diagnosis and treatment of diseases and for patient rehabilitation. Although the Medical Devices market in the New Zea...
FORMULATION AND EVALUATION OF FAST DISINTEGRATING LOSARTAN POTASSIUM TABLETS BY FORMAL EXPERIMENTAL DESIGN
In the treatment of hypertension fast onset of action is the major concern. The problem of slow onset of action of drugs can be overcome by development of appropriate dosage forms. Fast disintegrating tablets in mouth ar...
QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM
The present paper reports a highly selective, sensitive and robust stability indicating RP-HPLC method using QbD approach, developed and validated for determination of Artemether and Lumefantrine in combined dosage form....
Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU
Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the ind...