Essays on Medical Device

A Summation Of The Safe Medical Devices Act

The SMDA Act is an act that sanctions the progressive reporting as well as tracking the regulations for the use of the medical devices. The medical devices defined under the Act involve the devices classified within the consent of the Medical Device Regulation Act. The Act is responsible for the mandate of reporting the requirements made by the manufacturers of medical devices. The requirements hold with regards to the safety events as well as the product efficiency of the said devices. Based on the Act, the devices are classified with a substantial equivalence to the class II medical devices ( ...

VA Hospital

When considering the VA, many do not think about the technology behind the institution. By some it is considered run down and dreary, too behind the times to have the technology necessary to draw hackers out of their lairs. By others it is considered a medical stronghold for America’s soldiers. By those who work at the Veteran’s administration, they are aware that since 2009, 181 pieces of electronic medical equipment were infected with Malware, leaving them vulnerable to cyber attackers and hackers. One may ask why a cyber attacker would target the Veteran’s administration, or what ...

20 April 20, 2016

Qatar German Co. Med manufactures various medical devices and its headquarters is located in the Middle East. Their website states that they house a “state of the art production facility” and that they design, manufacture, and deliver quality and innovative medical devices. The company mentions that it partners with technology providers from Germany, Switzerland, and Italy in order to provide innovative products. The company anticipates a rapid growth in the market for medical devices as their demand is widespread worldwide. Although the company projects rapid growth in the future for medical device manufacturing, the industry ...

Questions

1. What is the procedure for the approval of a medical device? The FDA's Centre for Devices and Radiological Health executes this mandate. They have the final say on who manufactures, repackages or imports medical devices for use in the US. The medical devices are grouped in classes: I. II and III. These classes depend on the need for controls, exemptions and premarket approval. There is an increasing severity of the regulation procedure from class I to Class III (FDA, September 2014). The following are steps that are followed in the registration and regulation procedure. First, the sponsor (manufacturer ...

Health Care Course Work

1. Demographic: It is a term used in reference to statistical description of a population when dealing with societal aspects such as policy formation, marketing, and health care provision. Some of the aspects that are examined to give statistics in demographic are: age, race, location, home ownership, and disabilities, and ownership. For instance in reading B on the medical device daily, the term demographic is used in reference of proving that the elderly are outstripping health care capacity in Chicago. 2. Culture: the term is used to depict various meanings all of which can be summarized into three major meanings. ...