Challenges and obstacles for the U.S. medical device laboratory in performing environmental monitoring

The Global Medical Device community has for several decades relied on Mexico, specifically the industrial community, for the manufacture of their medical products. This manufacturing process has evolved over the years to result in an industrial conglomerate that has paid off in dividends to the Original Equipment Manufacturers (OEM) as well as the contract manufacturing industry in Mexico.

MAQUILADORA INDUSTRY
The United States, as well as other countries, utilize the services of Mexico to manufacture their medical devices in facilities collectively called the Maquiladora Industry (pronounced maw-kil-adora).

The maquiladora industry is a shelter operation which manufactures foreign-owned medical devices in Mexican-owned contract manufacturing companies. These maquiladora operations are operated by both foreign citizens as well as citizens of Mexico. The average maquiladora can have from five to ten percent of foreign nationals operating the facility, with the remainder of personnel comprised of Mexican citizens.

U.S. products manufactured in a maquiladora facility are required to comply with current Good Manufacturing Practices (cGMPs). Products manufactured in these facilities must undergo the same scrutiny and compliance as is required for products manufactured United States. Medical device products must comply with CFR Title 21 Food and Drugs, Part 820 Quality System Regulations.