Cadrex Adds ISO 13485 Medical Manufacturing Certification to a Second Facility

March 18, 2026

Cadrex has successfully added its Agawam location as a second ISO 13485 certified facility for medical device quality management systems. This landmark achievement for the facility marks the company’s commitment to quality and excellence within the medical manufacturing field.

ISO 13485 is a regulatory compliance certification that is important for customers inside the medical device industry, as it creates a framework for which customers and regulators can ensure that manufacturers making medical devices are compliant with the quality standards necessary for the industry. Making medical devices is important work that requires high precision and in-depth quality measures to ensure the success of its life-saving applications.

By achieving this certification, Cadrex has not only expanded its compliant locations for their existing medical customers, but it also grants more capacity for new medical leaders who are looking for manufacturing partners within the US and North America.

The Cadrex Agawam facility has 300,000 sq.ft. of manufacturing space, where it primarily offers precision machining capabilities and mechanical/electromechanical assembly services. Agawam has over 150 CNC machines on site, including 2 fully robotic cells and the ability to machine in 3,4,5 +C axis. The facility now has it’s certifications for ISO 9001, ISO 1348, AS9100D, and is ITAR registered.

This monumental achievement highlights Cadrex’s unique ability to collaborate across it’s large North American footprint to serve their customers and grow their collective capabilities as a leading manufacturing partner for the medical, aerospace & defense, and ICT markets.