ISO 13485 certification plays role in expansion effort

January 30, 2009, Medical Design

PMC Medical’s recent registration to ISO 13485:2003 is one in a series of strategic steps to continue its growth in the medical device market, according to the Cincinnati-based company. “As a supplier into the implantable biomaterials and surgical device markets, ISO 13485 certification is a requirement to meet customer expectations,” says PMC President and fourth-generation Owner Lisa Jennings.

ISO 13485 certification is the fifth quality system that PMC (pmcsmartsolutions.com) has implemented and maintained with a perfect record. Registration comes on the heels of a $2 million-plus investment in its medical business over the past two years, including expansion with a state-of-the art clean room and all-electric Milacron Roboshot presses.

PMC’s contract manufacturing services include design for manufacturability, injection molding, assembly and packaging, and sterilization management.

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For more information, send email to [email protected].

PMC Medical Expansion & ISO 13485 Certification

Cincinnati, Ohio January 21, 2009

PMC Medical announces its recent registration to ISO 13485:2003, as one in the series of strategic steps to continue its growth in the Medical Device market and to support its proprietary PMC SMART SolutionsTM approach. Registration comes on the heels of over $2 million of investment in its Medical business over the past two years, including expansion with a state of the art clean room and all-electric Milacron Roboshot presses.

PMC Medical is targeted at complex medical device contract manufacturing for surgical devices, implantable biomaterials for Orthopedic, Spine, Cardiology and other applications, and PEEK and other high-temperature thermoplastic-based instrumentation.

“As a supplier into Implantable Biomaterials and Surgical Device markets, ISO 13485 certification is a requirement to meet our customers’ demanding expectations,” stated Lisa Jennings, President of PMC Medical, and the fourth generation owner. “PMC has always put our quality system at the core of our entire company. For PMC, our quality system is not a book of procedures, but how we truly run our business and essential to managing risk for our medical customers and ourselves.”

ISO 13485 certification is the fifth quality system that PMC has successfully implemented and maintained with a perfect record. “When customers visit our facility, they feel the difference in an organization where quality is truly the essence of our culture,” Jennings said.

After 80 years in business, PMC Medical enters into an elite group of ISO 13485 certified medical device contract manufacturers based in Ohio. “As a member of BioOhio and affiliated with several Indiana organizations, PMC is a part of an amazing opportunity and transition that is taking place in the Midwest. BioOhio has been essential to our growth and the state’s support of BioOhio’s programs is propelling Ohio to be one of the premier Lifesciences states in the U.S.,” said Jennings.

PMC Medical continues rapid expansion into medical device contract manufacturing, offering customers services including design for manufacturability, hyper-precision injection molding, complete in-house assembly and packaging, as well as sterilization management. PMC’s services are wrapped into a proprietary system called PMC SMART SolutionsTM.

With its headquarters in Cincinnati, Ohio and manufacturing facilities in Shelbyville, Indiana, San Jose Iturbide, Mexico and Wiesau, Germany, PMC offers a global presence to customers. In the U.S., PMC is becoming a critical part of the rise of Ohio as one of the fastest growing centers for medical devices.

For further information, please contact Ms. Lisa Jennings at 513-557-5222 / [email protected]

For more information, send email to [email protected].