United States of America is the biggest market of the world for medical instruments/ equipments but none of the Pakistani company can export to USA unless it has obtained GMP approval (Attachment-A or B of Import Alert 76-01) in addition to Device Listing and Establishment registration from United States Food and Drug Administration (US FDA). 

QS Pakistan has full expertise for GMP approval.

Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice' or QSR 'Quality System Regulation') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of food and pharmaceutical products including medical instruments and equipment..

In the US, the phrase "current good manufacturing practice" appears in 501(B) of the 1938 Food, Drug, and Cosmetic Act (21USC351). US courts may theoretically hold that a drug product is adulterated even if there is no specific regulatory requirement that was violated as long as the process was not performed according to industry standards.