Our Quality System

At Alleva Medical, quality is an obligation. Alleva Medical facility is certified to meet international quality standards in North America, Europe, Japan and China. We are FDA & CFDA registered, ISO 13485 / 9001 certified. Our facility is certified to manufacture CE, GS, FCC, UL, ETL and PSE electrical products. Our manufacturing processes will meet the European RoHS, WEEE and REACH requirements.


Alleva Medical Quality Statement:

  • ➢   Providing products that are safe and effective, and meet or even exceed our customers' expectations and regulatory requirements.
  • ➢   Upholding the integrity of our people, products, and processes.
  • ➢   Maintaining full conformance to our quality system and applicable regulatory requirements.
  • ➢   Driving continuous improvement through technological and operational excellence.


We also employ a series of modern risk management techniques that include: failure mode & effect analysis (FMEA), control plan, and statistical process control (SPC). At Alleva Medical, we are constantly on the look-out for ways to minimize defect rates and maximize the return of your projects with us.


A representative list of our testing equipments includes:

  • Tensile Test, Pull Test, and Leakage Test
  • Digital Light Level Meter
  • Coordinate Measuring Machine
  • Automatic Optical Inspection
  • Frequency Spectrum Analyzer, Faraday Cage,
  • Drop Test Platform
  • Transportation Simulation
  • Aging Test, Temperature-Cycle Test Oven
  • Class 100 Clean Bench for Microbiology and Bioburden Test