MedVenture Technology, a medical device design and manufacturing company and part of Helix Medical, announces the expansion of its operations into Costa Rica.
Helix Medical Costa Rica is now under the leadership of MedVenture as Helix Medical’s Minimally Invasive Solutions division and focuses on assembly manufacturing of minimally invasive surgical and catheter-based devices.
"We have continuously expanded our range of services since the facility’s opening," said Mitch Moeller, President and Chief Executive Officer of MedVenture. "We are now able to offer our customers offshore finished device manufacturing."
Helix Medical Costa Rica opened in 2012 and is located in The Coyol Free Trade Zone in Alajuela, Costa Rica. Hallmark medical manufacturing services available at the facility include thermoplastic and silicone molding, silicone extrusion, assembly, packaging, and full validation capabilities.
Helix Medical Costa Rica will be a FDA registered site as of January 1, 2015. The operation’s quality system is in compliance with ISO 13485, certified by DEKRA. The company sought FDA registration in order to manufacture complete medical devices and export into the United States.
Helix Medical has four other facilities that are FDA registered. These include two operations in California; MedVenture Technology in Indiana; and VistaMed, a Helix Medical joint venture partner in Ireland.