This marks Plexus’ fourth global manufacturing facility to achieve the highly complex accreditation
Plexus announced that its Azteca Manufacturing facility, located in Guadalajara, Mexico, achieved Federal Drug Administration (FDA) approval to manufacture finished, Class III medical devices.
This marks Plexus’ fourth global manufacturing facility to achieve the highly complex accreditation, which requires customer sponsorship, rigorous clinical data analysis and exceptional focus on quality and manufacturing capabilities.
Michael Tendick, Plexus Market Sector Vice President – Healthcare and Life Sciences, commented, “Class III medical registration represents the ability to manufacture the highest risk medical devices, as these products sustain and save lives. There is no tolerance for failure for these types of products. Plexus is pleased to continue to add to its global footprint of facilities, which offer the leading edge reliability, quality, technological capabilities and teams required to create these highly complex and regulated products.”
In addition to its global manufacturing footprint, Plexus offers considerable expertise to its Healthcare and Life Sciences customers throughout the product lifecycle. Through value-add services including product development, Supply Chain and Aftermarket Services, Plexus can provide its customers enhanced benefits, including improved time-to-market and solutions that enable cost competitiveness.
Since 1979, Plexus has been partnering with companies to create the products that build a better world. We are a team of over 19,000 individuals who are dedicated to providing global Design and Development, Supply Chain Solutions, New Product Introduction, Manufacturing, and Aftermarket Services. Plexus is a global leader that specializes in serving customers in industries with highly complex products and demanding regulatory requirements.
Source: Company Press Release