Quality systems serve two main purposes:


(1) to document your own procedures in order to ensure consistency across the company, and ultimately gain more business, and


(2) to be in compliance with various regulatory requirements, be it 21 CFR 820, European Medical Device Directives (MDD), ISO 13485 CMDCAS, as well as others.


If you designed a device and contracted the manufacturing to another company, you are required to have a quality system.


If you distribute devices in US market, and/or you import devices into US market, you are required to have a partial quality system.


If you are a medical device manufacturer, you are required to have a full-scale quality system.


We build a quality system that meets your needs, in coordination with your quality personnel, including training.