CARPINTERIA, Calif. (Sept. 10, 2008) — Medical components manufacturer Helix Medical L.L.C. has gained Class 7 & 8 clean room certification, in accordance with ISO 14644, for its Carpinteria operations, the company said.
In addition, APEC Asia, a manufacturing operation of Helix Medical, passed an ISO 13485:2003 certification audit, conducted at its medical manufacturing facility in Shenzhen, China.
APEC Asia is one of a small number of firms in mainland China to carry this certification, which attests to a quality management system designed and implemented specifically for medical devices, Helix said. APEC manufactures thermoplastic and silicone medical device components and subassemblies.
Helix makes and supplies its products to the medical device, health care, pharmaceutical, biotech and IVD industries.
Helix — a subsidiary of Freudenberg-NOK G.P. — and its manufacturing operations have taken significant steps to provide certified manufacturing environments for the fabrication, assembly and packaging of medical devices and components, said company President Thomas Vassallo. But beyond that, the new certifications demonstrate the firm's commitment to grow its capabilities as customers needs grow, he said.
“We are dedicated to providing exceptional customer value above and beyond industry regulations,” Vassallo said.