Plexus Secures FDA Approval for Class III Medical Device Manufacturing at Fourth Facility
Plexus announced on August 7, 2019, that its Azteca Manufacturing facility in Guadalajara, Mexico, has received FDA approval to manufacture finished Class III medical devices.
Plexus has expanded its global manufacturing capabilities with the FDA approval of its Azteca Manufacturing facility in Guadalajara, Mexico, for finished Class III medical devices. This certification marks the fourth Plexus facility globally capable of producing these high-risk, life-sustaining medical products.
The achievement requires significant customer sponsorship, rigorous clinical data analysis, and exceptional quality control. Class III devices are associated with the highest risk levels, demanding absolute precision and reliability in their manufacturing processes. According to Plexus, there is no room for error with these types of products.
Beyond manufacturing, Plexus provides comprehensive product lifecycle services to its healthcare and life sciences customers. These include product development, supply chain management, and aftermarket services, aimed at improving time-to-market and cost competitiveness for its clients.
Established in 1979, Plexus specializes in serving customers with complex product needs and demanding regulatory requirements across various industries. The company focuses on delivering integrated solutions from design to aftermarket support.