FDA Registered Facility Offers Finished Medical Device Manufacturing

Jeffersonville, Ind. October 20, 2014MedVenture Technology Corporation, 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.  All Helix Medical operations worldwide are ISO 13485 certified.

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About Helix Medical, LLC

Helix Medical, a division of the Freudenberg Group, is a custom manufacturer for the medical device, pharmaceutical, and IVD industries worldwide. Established in 1984, Helix Medical has medical manufacturing operations in California, Indiana, Massachusetts, Minnesota, Costa Rica, Germany, Ireland, and China.  www.helixmedical.com

About MedVenture Technology Corporation

MedVenture Technology Corporation - a Helix Medical company - designs, develops, and manufactures minimally invasive surgical and catheter-based devices for OEMs worldwide.  The company develops integrated solutions for the endovascular, interventional cardiology, cardiovascular surgery, neurovascular, urology, oncology, and gynecology markets, among others.  www.medventure.com