08.20.14
Helix Medical LLC, a manufacturer for the medical device, pharmaceutical and in-vitro industries, reports that medical device manufacturing operation located in Baldwin Park, Calif., has achieved U.S. Food and Drug Administration (FDA) registration. Helix Medical Baldwin Park became an FDA registered site as of Feb 14, 2014. The operation’s quality system is in compliance with FDA 21 CFR 820 as well as ISO 13485, officials said.
“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 at Helix Medical Baldwin Park. “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.”
Helix Medical has three other facilities that are FDA registered: the Helix Medical operation in Carpinteria, Calif.; MedVenture Technology in Jeffersonville, Ind.; and VistaMed, a Helix Medical joint venture partner in Carrick-on-Shannon, Ireland. All Helix Medical operations have ISO 13485 certification.
Helix Medical, a division of the Freudenberg Group, offers device and component design and development, silicone and thermoplastic molding and extrusion, complex catheter systems including hypotubes, as well as assembly, packaging, and validation and qualification services.
Established in 1984, Helix Medical has medical manufacturing operations in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.
“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 at Helix Medical Baldwin Park. “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.”
Helix Medical has three other facilities that are FDA registered: the Helix Medical operation in Carpinteria, Calif.; MedVenture Technology in Jeffersonville, Ind.; and VistaMed, a Helix Medical joint venture partner in Carrick-on-Shannon, Ireland. All Helix Medical operations have ISO 13485 certification.
Helix Medical, a division of the Freudenberg Group, offers device and component design and development, silicone and thermoplastic molding and extrusion, complex catheter systems including hypotubes, as well as assembly, packaging, and validation and qualification services.
Established in 1984, Helix Medical has medical manufacturing operations in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.