Helix Medical, a contract manufacturer that provides silicone and thermoplastic molding and extrusion services, has obtained FDA registration for its facility in Baldwin Park, CA.
"The registration was driven by a customer who approached us with the need to manufacture a new product requiring FDA registration," said Steve Gilder, Director of Quality, in a prepared statement. "We have continuously expanded our range of services at the Baldwin Park operation in recent years, and we are now able to offer our customers finished device manufacturing."
The company operates three other FDA-registered facilities: Helix Medical in Carpinteria, CA; MedVenture Technology in Jeffersonville, IN; and a joint venture with VistaMed in Carrick-on-Shannon, Ireland. All of its plants are certified to ISO 13485, the international quality standard for medical device manufacturing.
A division of the Freudenberg Group, Helix Medical offers a full range of medical manufacturing capabilities in addition to molding and extrusion that include device and component design and development, catheter fabrication, assembly, packaging, and validation and qualification services.