Precision Extrusion Certified for ISO 13485

Precision Extrusion Inc. (PEI) has been certified with ISO 13485:2003, the quality management standard for medical devices.

The company reported completing a four-day audit with zero observations. According to company officials, the auditor claimed that this was the first time he has recommended certification for a company such as Precision Extrusion on a first audit.

The certification was provided by Intertek Testing Services NA Ltd.

Company President Mike Badera thanked the entire PEI team for “focusing on the increased quality requirements coming from our partners in the medical device industry.”

Rosy Wang, the company’s vice president and chief operating officer, spearheaded the effort.

“By achieving this recognition, Precision Extrusion Inc. has raised our internal quality system to the highest ISO standard for component manufacturers, which will allow us to continue to provide the best possible products and support to our customers in the very demanding medical device industry,” Wang said.

Precision Extrusion is a Glen Falls, N.Y.-based contract manufacturer of medical device components and sub-assemblies based on extruded thermoplastic tubing.

The company primarily serves medical device firms in the endovascular, cardiology, radiology, neurology, orthopedic and dental sectors. It also manufactures some specialized products for application in the fiber optic industry and for precision measurement systems.

In 1998, the company was first certified to ISO 9001 and has maintained the certification since then. .