At Seisa Medical, we have extensive experience and a wide range of expertise in medical devices, creating innovative services ranging from design, development, or manufacturing high-volume precision components and assembly manufacturing. We build a portfolio of end-to-end solutions for the lifecycle of medical products.
Our trajectory began in 1983, the year it was founded from the vision of Julio Chiu, our CEO and founder. Since then, 40 years have passed, and Seisa has continued growing, expanding its reach and impacting the lives of many medical patients.
In the first years of the company’s life, Seisa established itself in one of the most productive borders of North America, opening its two central locations in Ciudad Juarez and El Paso.
Through the years and thanks to hard work, Seisa Medical has expanded its operations to more than 350,000 feet of manufacturing area, divided into different locations in Mexico, USA and Europe. Consequently, these operations have opened the doors to more than 2,500 workers.
Despite this massive scaling, the corporate headquarters of Seisa Medical is in El Paso, Texas, since essential factors for the medical device industry converge in this region, such as the proximity between Mexico and the United States and the fast communication with cities like San Francisco or New Jersey.
This has led Seisa to positively impact the region known as Borderplex, attracting new methodologies and processes from high-end companies and expanding the knowledge and perspective of engineers in the area.
Through strategic acquisitions and a global vision, we have expanded our operations worldwide. All this is to create logistics processes that meet our customers’ needs. Each of our sites specializes in different approaches, making them part of a strong network.
Seisa Juarez is the leading site thanks to its location on the northern border of Mexico, just 15 minutes from the border crossing with the United States. In addition to its high-quality labor force, it ranks as one of the most qualified worldwide thanks to its broad vision of the industry, the sense of responsibility, and the certifications in place.
This location has 275,000 square feet of space, a large facility that allows for diverse operations, including class 7 and 8 clean rooms, ideal for manufacturing medical devices to high-quality standards.
This diversity and strict sense of quality have allowed for the manufacture of medical devices that meet the needs of any OEM looking to manufacture Class II and III devices.
Seisa Juarez can also assist in 510K generation for catheter-based devices, including microcatheters, guide catheters, and balloon catheters.
Seisa Bay Area
This Seisa Medical headquarters has an extension of more than 30 thousand square feet, concentrating functions focused on biotechnology and medical devices. Specialized solutions such as injection molding, mold making, and prototyping of plastics and metals are concentrated here.
The operations in the Bay Area, as in our other locations, position us as one of the most competent and complete companies in the healthcare sector. Capabilities such as advanced machining and laser cutting, and welding stand out and earn the trust of our customers and partners.
We are also a trusted supplier of complex metal components and mechanical assemblies for R&D prototyping.
The San Francisco facility has an ISO Class 7 certified controlled environment room and employs highly trained and skilled personnel to manufacture healthcare devices. In addition, we use state-of-the-art methodologies and processes, making us one of the best options for developing the instruments above.
Seisa New Jersey
In the spring of 2019, Seisa acquired Burpee MedSystems in Eatontown, New Jersey. This location consolidates the Seisa experience, specializing in developing and manufacturing implantable stents and delivery devices, with expertise in laser machining, surface finishing, nitinol forming, shaping, and welding.
The Seisa New Jersey capabilities allow us to guide our clients throughout the entire product development process, from conceptualization to approval by the FDA. This gives way to a company specializing in high-volume manufacturing of Class II and Class III devices and complex components such as stents, heart valves, and delivery systems.
Seisa Myjav, Slovakia
One of the milestone locations in our global vision is Seisa Europe in Myjava, Slovakia, established in 2006. Due to the market’s needs, Seisa expanded to Slovakia to support our European customers.
Positioning ourselves in the Slovakia region would respond to new operational needs in countries such as Denmark, Ireland, or Spain, such as production, assembly, distribution, and logistics.
The Seisa team in Europe mainly manufactures implantable and life sustains devices for OEM customers in Europe.
The existence of Seisa Europe is a manifestation of our constant search to be the ideal support for our customers no matter where they are or where they need to export to, overcoming any challenge together.
A constant expansion
Having a presence in different regions of the world gives us the perfect panorama to innovate and propose within the medical industry. From North America to Europe locations, the Seisa sites are critical to our supply chain, each contributing to the comprehensive services we provide to our customers.
At Seisa Medical, we are committed to meeting the highest standards for our products and manufacturing processes. Our facilities are FDA-registered and ISO 13485 compliant, ensuring that we meet the most stringent requirements for quality and safety.
We received our first FDA 510K approval in 2015 and have since obtained licenses for additional products. Our processes are regularly audited to ensure that they continue to meet FDA requirements for Class I, II, and III products. With our commitment to quality, Seisa Medical is your partner for reliable and safe medical devices.
The worldwide impact of medical devices
Medical devices play a vital role in healthcare worldwide, and they are used in many procedures, from lifesaving surgery to routine check-ups. According to global reports, the medical device market was worth an estimated $334 billion in 2021, and its growth will reach $657 billion by 2025.
However, like any product focused on human health, medical devices must undergo a classification system and review process established by the US Food and Drug Administration (FDA).
There are three main categories of medical devices
Class I medical devices
Class I devices are considered low risks, such as bandages, hand-held surgical instruments, tongue depressors, stethoscopes, and even traditional wheelchairs.
It is estimated that 47 % of all medical devices fall into this classification, with only 5 % requiring regulation. Only in this small percentage is a marketing application to the FDA needed.
Class II medical devices
Class II devices are considered a moderate or intermediate risk to the patient. This category includes some types of catheters, implantable stents, power wheelchairs, pregnancy test kits, infusion pumps for intravenous drugs, or computed tomography (CT) scanners.
Currently, 43 % of medical devices belong to Class II. Due to the risk they may pose to the user, this category already requires regulation by bodies such as the FDA.
Class III Medical Devices
Medical devices classified as Class III are vital instruments to maintain or support the life of patients, so they represent a high risk and must be strictly regulated.
In the market, only 10% of devices fall into Class III, including some examples such as implantable pacemakers, heart valves, deep brain stimulators, unique surgical implants, breast implants, and plastic injection molding for extrusion assemblies and tubing.
One of the essential applications of medical devices is in the field of pediatric and orthopedic care. Pediatric patients require specially designed products considering their smaller size and different anatomy. On the other hand, orthopedic patients often need devices to help them regain movement or relieve pain. In both cases, Seisa Medical offers a wide range of solutions that meet the needs of these patients.
The worldwide impact of medical devices is evident in developed and developing countries. In developed countries, they play a vital role in ensuring that patients receive the best possible care, and in developing countries, they can help close the gap in access to healthcare services. No matter where they are used, medical devices make a positive difference in patients’ lives worldwide.
How our work has changed lives
Medical devices have the potential to change lives. They can provide people with greater independence, enable them to return to work or school, and improve their quality of life. Seisa Medical is a leading provider of medical devices, and we are committed to helping our patients lead fuller and more active lives.
This quest to impact the lives of people with medical problems and to provide solutions to our client’s issues has led us to develop various services and capabilities. Do you need advice with any procedure? Do not hesitate to contact us.
- Product Design and Development
- 510K Generation and Regulatory Support
- Medical Device Prototyping
- Process and Tooling Design
- Design of Delivery Systems and Components
- Material Selection
- Testing Capabilities
- Collaborative Project Transfers
- New Product Introduction
- Supply Chain Solutions
- FDA Registered Products
- Medical Device Manufacturing
- Implantable Components and Delivery Systems
- Injection Molding
- Medical Extrusion
- Laser Cutting & Welding
- Nitinol and Specialty Alloy Solutions
- Metal Processing Technologies
- CNC Machining and EDM
- Wire Forming
- Mold Making
- Plastic Prototyping
- Catheter Solutions
- Balloon Forming