Precision Coating First to Receive ISO 13485 Certification

Posted Mar 24, 2015 12:00:00 AM
By Precision Coating

Precision Coating Continues to Invest, Improve, and Innovate on Core Coating Technologies, Exceeding Expectations of Medical Device Manufacturers Worldwide

IMG_1083.jpgBoston, MA -- 03/24/2015 -- Boston-based Precision Coating Co., Inc. (PCCI), is pleased to announce that its quality management system has been evaluated and found to be in compliance with the International Organization for Standardization (ISO) 13485:2003 standard. Being the first medical device coating applicator to receive this certification, PCCI further endorses its commitment to remain an innovative world leader in the medical device coating industry, consistently meeting and exceeding customers' quality, safety, and performance expectations. PCCI has been assessed and certified by the Notified Body, SGS United Kingdom Limited (accredited by UKAS under registration number 0005), which covers the operational activities for the application of polytetrafluoroethylene (PTFE) and related fluoropolymer coatings on medical devices.

Robert A. DeAngelis, President of PCCI said, "We are proud to be the first PTFE medical device coatings applicator to obtain ISO 13485 certification. Achieving the certification supports our medical device coatings business strategy in leading the PTFE coating application industry and bringing it to higher standards. We have created a quality-driven culture that establishes, as priority number one, to deliver coated medical device components that produce successful patient outcomes."

Natalya Koshnitsky, Director of Quality at PCCI, said, "Our team has worked tirelessly to raise the bar on quality and respond to market demands for tighter controls, quality standards, and service levels. Passing the certification audit without any non-conformances is an ultimate sign—testament to our business model—to continuously improve our quality system and deliver high-quality product per customer requirements."

Being the first medical device coating applicator to meet the stringent requirements set forth in ISO 13485—validating its facility, quality system, and procedures—PCCI continues to assert its position as a leader in the medical device coating industry.

About Precision Coating, Co., Inc.
Precision Coating Co., Inc., a Katahdin Company, serves global health care and medical device companies around the world, coating medical devices such as guide wires, core wires, hypotubes, and forming mandrels. PCCI has the ability to work with customers from concept to commercialization and has two facilities—one dedicated to flexible prototype work and one dedicated exclusively to high-volume medical device coating applications.

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