The NEI company just announced that they achieved the ISO 13485:2003 Medical Device Quality Management System certification for their main facility in Texas. The ISO 13485:2003 is to “facilitate harmonized medical device regulatory requirements for quality management systems, and its requirements are unique to organizations building medical devices”. The company is already ISO 9001:2008 certified.
NEI is a global leader in providing application platforms, development solutions and lifecycle support services for software developers. The article mainly examines the high standards that they set for their medical software devices and services. They play a huge role in IT software service to the healthcare industry all over the world.
In order for NEI to receive this certification, they had to develop and then implement quality management policies for medical devices. The standard for the ISO 13485:2003 requires any company to consistently provide medical devices that meet the customer and the regulatory requirements. In the article, it seemed as though NEI welcomed audits and management evaluations because they work with medical devices. John Gauthier, the director of quality assurance at NEI said, “NEI recognizes the strict parameters and regulatory requirements involved in medical device manufacturing and has developed rigorous practices in support of those metrics”.
The IT standards that NEI sets for the healthcare industry is important. I believe that they should be keeping those standards high because of what industry they are in. They also seem to take pride in their standard of quality, which must mean that it is excellent. Those medical devices that they create should have high quality because will essentially be used in dealing with people’s lives. It is said in the article that they intensely listen to their customer base so that they can keep improving and changing with the times. This kind of close attention to detail will benefit NEI in the future because their customers know that they can count on them to maintain the best quality management.
The link to the article as well as a link to NEI’s website is below:
http://www.onlinetmd.com/nei-certification-medical-devices-102312.aspx
http://nei.com/default.asp?LINKNAME=QUALITY
I would have to agree, the standards set by NEI for medical manufacturing are very important to the healthcare industry. I think, when dealing with anything that has to do with medicine, the highest standards need to be maintained. Health is one of the most important aspects of our lives, without our health we are incapacitated. Companies who achieve high standard qualities such as these can show the consumer how much they really care about them.