Helix Medical attains FDA registration

Baldwin Park, California – Officials from Helix Medical LLC announce attainment of FDA registration for its medical device manufacturing operation located in Baldwin Park, California. 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.

“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, these include the Helix Medical operation in Carpinteria, California; MedVenture Technology in Jeffersonville, Indiana; and VistaMed, a Helix Medical joint venture partner in Carrick-on-Shannon, Ireland. All Helix Medical operations have ISO 13485 certification.

Helix Medical offers the following medical manufacturing capabilities around the globe: 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. 

Source: Helix Medical