Helix Medical is proud of the rigorous focus we place on quality.
We work hand in hand with our customers to implement customized validation and quality control plans to insure compliance with all customer, FDA and ISO requirements.

• ISO 13485 : 2003
• CDHS Licensed Medical Device Manufacturer
• FDA cGMP compliant
• Climate Controlled Metrology Laboratory
• First Article Inspections
• Capability Studies
• Gauge R&R