Extensive on-site audit of Contract Manufacturing campus results in re-approval through 2022
SAN MARCOS, Calif. – December 10, 2021 – Brightworks Technology, Inc., a global leader in providing Contract Manufacturing Services (CMS) and AC/DC power solutions to OEMs worldwide, announced that its manufacturing location in Long Khanh, Vietnam has been awarded the renewal of its ISO13485 quality management compliance certification.
The independent international global leader in medical certifications, SGS Société Générale de Surveillance (“SGS”), conducted an extensive 3-day audit of the company’s manufacturing operation and renewed the company’s high-volume, vertically integrated manufacturing facility for medical products according to ISO13485 certification.
The international ISO13485:2016 standard is a global harmonized standard for quality management as maintained by the International Organization for Standardization (ISO). This standard of quality excellence is widely used to train and manage medical product manufacturers in documentation, traceability and quality disciplines within the medical device industry. The standard’s intent is to support OEMs and consumers that the products made under the umbrella of this standard are safe for their intended purpose.
“We are very proud of our management team, and more than 1,600 employees at this facility for achieving this global recognition,” noted Robert L. Carl, president of Brightworks Technology, Inc. “As a contract manufacturer, it is crucial to our medical device customers that we not only have this system in place but that we execute the highest level of quality in our day-to-day operations. Our customers are assured that we have a solid foundation of quality recognized internationally.
For more information on Brightworks’ manufacturing capabilities, call 858-275-6423 or visit the website at: www.brightworks-usa.com
About Brightworks Technology, Inc.
Headquartered in San Marcos (San Diego) Calif., Brightworks Technology, Inc. is a wholly-owned subsidiary of Group Intellect Power Technology Limited. The global Company builds OEM products for global customers in its Contract Manufacturing Services division. The Company also provides contract manufacturing services (CMS) along with value-added services such as plastic injection molding, cables and harnesses, and high-volume printed circuit board assembly using surface mount technology (SMT). The Company also designs and manufactures AC/DC power conversion products, including power supplies, as well as battery chargers and external power adapters from 1 to 3,000 Watts for both medical and industrial applications. With over 3,500 employees worldwide, three manufacturing campuses, and three R&D locations, the Company manufactures consumer electronics and electro-mechanical products, including radio frequency, audio and video electronics, and other electro-mechanical products from its global manufacturing and design facilities. For more information, visit www.brightworks-usa.com and on LinkedIn.