• 
  ISO 9001

  The ability to consistently provide products and services that meet customer and regulatory requirements

• 
  ISO 14001

  A framework for an effective environmental management system (EMS)

• 
  ISO 13485

  Medical equipment and quality management systems that always meet customer and regulatory requirements

• 
  ISO 14644

  The procedure & apparatus carried out for the air cleanliness class. A class 100,000 cleanroom ready for production now.

• 
  MDR

  The new European Medical Device RegulationUnder processing now

• 
  FDA

  U.S. - The Food and Drug Administration. FDA 510(k) cleared

The ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements