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ISO 13485 Approved

November 13, 2012

Total Life Sciences Receives ISO 13485 Certification

Fort Wayne IN - Total Life Sciences, a division of Total Plastics Inc. specializing in the distribution of stock shape plastic materials made from medical grade polymers, was approved on Nov. 1 by American Systems Registrar (ASR) for ISO 13485 Certification.

What: AAOS 2013 Annual Meeting
When: March 20-22
Where: McCormick Place in Chicago
Booth: Find us at booth 3300 in Hall A

Recognized worldwide by larger original equipment manufacturers and smaller producers alike, ISO 13485 Certification is the standard for the design and manufacture of medical devices and equipment, ensuring quality, safety and effectiveness of all processes.

“We are proud to make this announcement and it exemplifies our commitment to the orthopedic and medical device markets, ” said Michael Kell, Business Development Manager for Total Life Sciences. “It is one of many steps taken to provide our customers with the continuing support they have come to expect from our company.”

Total Plastics was approved for it’s ISO 9001:2008 certification in May of 2010 by ASR, an accredited third-party registrar specializing in international standards in the manufacturing and servicing markets.

“With the rigorous requirements from the regulatory community, we deemed it necessary to compliment our ISO 9001:2008 certification with ISO13485,” Kell said. “Our team has worked very hard to make this accomplishment a reality.”

Total Life Sciences, headquartered in Fort Wayne, is a leading supplier of medical grade plastics stock shapes. Their knowledgeable and dedicated staff is trained to provide solutions to a variety of product and device applications through all stages of the development and manufacturing process.