Medical device: a complete overview

Abstract

Medical device means any instrument, apparatus, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose. Medical devices are generally classified based on risks; the actual risk-based classification of the medical device depends upon its intended use and purpose. Development of an entirely new device typically begins with a concept by a physician or bioengineer for a solution to a medical problem. If the idea is determined to be workable and practical (proof of concept) an early design of the device, known as a prototype, will be built. A prototype device will undergo a cycle of preclinical testing, redesigning, preclinical testing of the redesign and so forth, until the design has been refined and tested to a point that it is ready for production and testing in humans. Preclinical animal tastings are conducted to provide reasonable evidence that novel technologies and therapies are safe and effective. When studying medical devices, clinical trials are not always required, and whether or not one will be conducted depends on a risk assessment. Post marketing surveillance is the practice of monitoring the safety of a medical device after it has been released on the market.