Upchurch Medical Receives ISO 13485 Certification

•Brochure: Upchurch Medical's Capabilities

Upchurch Medical has received ISO 13485:2003 certification for its manufacturing facility, located north of Seattle, Washington. Lloyd's Register Quality Assurance (LRQA) performed the audit in January 2006 and recommended Upchurch Medical for certification immediately thereafter.

Upchurch Medical is a contract manufacturer of medical device components, with molding, extruding, machining and assembly capabilities as well as a Class 100,000 clean room. Upchurch Medical specializes in working with high performance engineering thermoplastic materials and manufactures components that are used across a variety of medical applications, including spine, orthopedics, cardiovascular, endoscopy and interventional radiology.

Upchurch Medical's achievement in reaching ISO 13485 certification demonstrates their dedication to quality and customer service, a sentiment that is also expressed in their quality policy which reads: "To manufacture safe, effective and reliable medical components that consistently bring value to the customer and are technically and clinically competitive worldwide."

In addition to ISO 13485 certification, Upchurch Medical is also actively seeking FDA registration and anticipates completion of this in the near term.

ISO 13485:2003 is the international standard developed for medical device and component manufacturers. To be certified to this standard, companies must complete a rigorous auditing process proving that their quality systems meet ISO principles such as customer focus, process traceability, and dedication to continuous improvement.

•Brochure: Upchurch Medical's Capabilities

SOURCE: IDEX Medical