ISO & FACILITY STATEMENT
Helix Medical, Inc.’s newly expanded campus buildings are dedicated to the manufacturing, assembly and quality assurance of the product line for the Biomedical/Pharmaceutical industries. All of our production facilities are environmentally controlled and feature technologically advanced production equipment, including extruders, transfer/compression presses and liquid injection molding machines.
Helix Medical, Inc. certifies that our platinum-cured silicone products are manufactured following Good Manufacturing Practices (GMPs) in accordance with the Quality System Regulation in an FDA registered medical device facility. Helix Medical, Inc. has been certified to ISO 9001/ EN 46001 quality standards. Our products meet USP Class Vl-XXIII biocompatibility requirements, and can be sterilized by steam, ethylene oxide, dry heat and/or gamma radiation within the user’s validated cycles and exposure levels. These platinum-cured silicone products have full traceability to raw materials and contain no peroxide catalysts.
Registered Medical Device Manufacturer (State-Federal FDA).
Quality Systems certified to ISO 9001/EN 46001 quality standards.