Helix Medical LLC's Baldwin Park, Calif., facility has attained compliance with the federal regulation for quality systems for medical devices.
The facility received the Food and Drug Administration registration for complying under the code of federal regulations' title 21 part 820 and also gained certification under the standard for ISO 13485 quality management systems.
Helix pursued the registration and standard to fulfill a customer's requirement for production of a fully assembled polypropylene multi-component Class II medical device.
Steve Gilder, director of quality, said the Helix facility expanded its range of services to include validations and assembly of medical devices in addition to its previously existing validations of medical device components.
“We are just now completing all validations and beginning to manufacture finished medical devices to expand core competencies for our customers,” Gilder said.
In 2009, Helix converted existing warehouse space into two Class 8 clean rooms of 7,400 and 870 square feet and an assembly-dedicated Class 7 clean room of 3,500 square feet. A previously existing 10,000-square-foot Class 8 clean room remained in use.
Helix employs about 186 and occupies 72,000 square feet in Baldwin Park. The site has more than 60 injection molding machines of which 80 percent process thermoplastics using clamping forces of 28-350 tons.
The supplier to the medical device, pharmaceutical and in-vitro-diagnostics industries has three other FDA-registered and ISO 13485-certified operations including its Carpinteria, Calif., headquarters; MedVenture Technology Corp. with a Jeffersonville, Ind., facility and a Minnetonka, Minn., office; and VistaMed Ltd., a joint venture with entrepreneur John O'Shaugnessy in Carrick-on-Shannon, Ireland.
Other Helix Medical manufacturing facilities are located in Gloucester, Mass.; Alajuela, Costa Rica; Kaiserslautern, Germany; Shenzhen, China; and Spiddal, Ireland, the latter for Cambus Medical, another O'Shaugnessy joint venture, which also has a US office in Murrieta, Calif.
Helix is a division in the seal and vibration technology group of family-owned Freudenberg & Co. KG of Weinheim, Germany.
A Freudenberg unit obtained the Baldwin Park, Carpinteria, Gloucester and Shenzhen facilities in its late 2007 acquisition of the assets of Anura Plastics Engineering Corp.
