Seisa Medical Product Development
About the company,
Seisa was founded in 1983 by Julio Chiu, CEO and Chairman of the Board with the corporate headquarters in El Paso, Texas. Now, they have a presence spanning four countries on three continents, with approximately 2,500 employees. They received the first of several FDA 510K approvals for Seisa devices in 2015. Seisa currently manufactures catheter-based products, implantable stents, tubing sets, pediatric and orthopedic-care products, among many others. Seisa’s Facilities are located in El Paso, TX, and Eatontown, New Jersey, USA, in Myjava, Slovak Rep, Cd. Juarez, Mexico and Hong Kong, PRC.
Video Credits to Hecho En Juárez
Seisa is a medical device manufacturer serving every stage of the product life cycle including design and development, component manufacturing, and final assembly. Seisa delivers with full regulatory compliance.
Mission and strengths,
For nearly four decades, Seisa has emphasized the importance of investing in its people. They have talent and trained engineering resources with enough knowledge in regulatory policies for medical device manufacturing. Just as they value the people receiving their products, we value those who make them. In turn, our high retention and stable workforce underpin steady, mass-volume production.
SEISA’s strengths are the following:
- Vertically integrated operations to speed time to market and control costs.
- Expertise in manufacturing FDA Class I, II, and III products.
- Mastery in engineering and executing product transfers between facilities.
- Expansive experience with a range of materials and designs.
- Expansion of partners’ production capability and capacity at optimal cost.
The BIO El Paso - Juárez member has experience by working with some of the world’s largest medical device companies, SEISA today is anchored by a regulatory-focused culture (FDA-registered, ISO-certified) committed to delivering lean initiatives to drive savings and improvements. These provides a strong portfolio of resources and capabilities as:
- Product Design and Development
- 510K generation
- New Product Introduction
- Injection Molding
- Laser cutting
- Welding technologies.
Through the new acquisitions in the bay area of CA, they offer additional capabilities like Mold Making, Plastic and Metal prototyping, CNC Machining. Also, new capabilities are in place for coextrusion, multi-lumen extrusion, micro-molding, and balloon catheter manufacturing.