With 30 years of organic growth, Seisa provides a strong portfolio of resources & capabilities to meet your most challenging objectives.
At Seisa, trust is central to every partnership. Our primary focus in every area of service is that what we manufacture, what we promise, and what we deliver could change a human life.
From our founding, our core tenet has been to hold every employee responsible for adherence to FDA and international regulations.
That standard has been maintained from Seisa’s original plant established on the US-Mexico border in 1983, to the 270,000 sq ft of manufacturing space we operate today across the globe. With 120,000 sq ft of cleanroom capacity, 510K generation services, state-of-the-art prototyping and testing technology, and vertically-integrated device manufacturing capabilities, Seisa is independently equipped to provide any solution our customers require.
Our success is grounded in our communities. For nearly four decades, Seisa has emphasized the importance of investing in its people. Just as we value the people receiving our products, we value those who make them. In turn, our high retention and stable workforce underpins steady, mass-volume production.
Seisa at a Glance
- Seisa was founded in 1983 by Julio Chiu, CEO and Chairman of the Board.
- Our manufacturing sites are FDA registered and ISO 13485 compliant.
- Our corporate headquarters is in El Paso, Texas.
- Our presence spans four countries on three continents, with approximately 2,300 employees.
- Seisa operates 270,000 square feet of manufacturing globally including 120,000 square feet of cleanroom capacity.
- Seisa has successfully vertically integrated its offerings to customers through strategic acquisitions in molding, extrusion, and product design.
- Seisa leverages its globally strategic locations across North America, Europe, and Asia to offer full turnkey supply chain services to our customers.
- We received the first of several FDA 510K approvals for Seisa devices in 2015.
- We currently manufacture catheter-based products, implantable stents, tubing sets, pediatric and orthopedic-care products.
- Seisa processes comply with FDA requirements for Class I, II, and III products.
Who We Are
Seisa delivers Class III compliance at every step of the product life cycle to deliver exactly what you need to get your medical device to market. From 510K Generation to prototyping to final assembly, our ISO-certified medical manufacturing facilities provide the advanced materials and processes your business requires.
Our range of comprehensive services and vertical integration mean fewer delays, greater flexibility, and increased productivity that you can pass on to your customer.
Regional development, worldwide influence
As contiguous cities, El Paso and Juarez form a binational metro area that is culturally unique and expert in cross-border trade. With Mexico ranking ninth on the planet and first in Latin America for medical device exports, a group of manufacturing firms have committed to capitalizing on the area’s rich acumen as a global hub for medical manufacturing.
The BioMed Cluster unites leaders in academia, research, and manufacturing to boost the region’s economic growth and competitiveness in the medical manufacturing sector. Lower costs for research and development and payroll on the Mexican side of the border offer substantial advantages to businesses based minutes away in the United States. The Cluster’s board president, Seisa’s founder and CEO, Julio Chiu, brings 30 years’ experience in the field to the group’s administration.
The goals and benefits of interdisciplinary collaboration are profound and far-reaching. Among them are access to a stable, qualified, and efficient workforce, expansion of training programs in FDA regulatory compliance and audits, broad support for expediting international permits, leveraging group purchasing for greater supply chain efficiency, and creating a training center for best practices in medical manufacturing.
These and other initiatives made possible by Cluster cooperation will foster greater innovation, more clinical studies in Mexico, and increased national investment in the sector. Seisa is proud to be a driving force behind these developments.