CANTON, Mich., Sept. 5 /PRNewswire/ -- Creative Technology Services, or CTS, (http://www.ctsmius.com) announced that it has received certifications for international quality standards for the most stringent medical devices by the Food and Drug Administration (FDA), and from TUV America. The company is continuing to focus on its growth in the medical device industry, since its management buyout of the company from well-known automotive supplier MSX International, last year.
CTS has the facilities and certifications to accommodate the manufacturing needs of the most sophisticated medical devices and products with its Class III FDA Registered Facility. Class III is the most stringent regulatory category in the healthcare industry and therefore allows CTS to manufacture equipment with lesser regulatory requirements as well, such as Class II medical devices, which represent the vast majority of them.
In addition, CTS is radiation-certified by the federal and state regulators, which means that it is licensed to work with radioactive materials.
CTS has also obtained ISO 13485:2003 certification, which specifies requirements to ensure that the devices consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Finally, ISO 9001:2000 certification was also granted. This specifies requirements to ensure the organization's ability to consistently provide product that meets customer and applicable regulatory requirements and to enhance customer satisfaction through the assurance of conformity to customers and applicable regulatory requirements.
"These certifications will give us the firepower to support more of our
customers that deliver complex medical products throughout the world," said
Don Leith, President and CEO of CTS. "We are already known for our passion
for quality and for making the differences to the end-users; these
|SOURCE Creative Technology Services|
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