Electronics Manufacturer Achieves ISO 13485:2003 Certification

Aug. 23, 2006
Gowanda Electronics is now registered as conforming to ISO 13485:2003 quality management standard by NSF International Strategic Registrations, Ltd.

Gowanda Electronics, a manufacturer of inductors, is now registered as conforming to International Organization for Standardization (ISO) 13485:2003 quality management standard by NSF International Strategic Registrations (NSF-ISR). The audit was completed by NSF-ISR in the second quarter of 2006.

ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. This ISO certification is applicable to organizations that are involved in the manufacture of medical devices, and to companies like Gowanda Electronics that manufacture components for such devices. Gowanda states that they are the first inductor manufacturer to attain ISO 13485, establishing Gowanda Electronics as a leader in this field.

David Schaack, President of Gowanda Electronics, said, “We’ve been supplying components, mostly on a custom basis, to medical device manufacturers for several years. By making the business decision to achieve our ISO 13485 certification now, we are demonstrating our commitment to the global medical device marketplace and leading the way in addressing requirements which will become essential to doing business in the medical community in the months and years ahead.”

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