Seisa
Seisa Medical is a vertically integrated medical device CDMO providing end-to-end design, FDA 510K regulatory support, and Class II/III contract manufacturing for medical device OEMs in cardiovascular, neurovascular, endovascular, peripheral vascular, dialysis/drug delivery, and orthopedic applications across the US, Mexico, and Slovakia.
- Company typePrivate
- Founded1983
- HeadquartersEl Paso, United States
- Headcount1,001–5,000
- GTM typeB2B
- OfferingServices
What Seisa does
Seisa Medical is a vertically integrated medical device contract development and manufacturing organization (CDMO) headquartered in El Paso, Texas. Founded in 1983 by Julio Chiu, the company delivers end-to-end services spanning product design and development, regulatory support (FDA 510K), component manufacturing, and final assembly for Class II and Class III medical devices, serving medical device OEMs across endovascular, cardiovascular, neurovascular, peripheral vascular, dialysis/drug delivery, and orthopedic applications. Core manufacturing capabilities include injection molding, medical extrusion, laser cutting and welding, Nitinol and specialty alloy processing, CNC machining and EDM, mold making, plastic prototyping, catheter solutions, and balloon forming, with a stated footprint of approximately 2,500 employees across facilities in El Paso, Juárez (Mexico), Eatontown (New Jersey), the San Francisco Bay Area, and Myjava (Slovakia), supported by 350,000+ square feet of manufacturing space including 150,000 square feet of Class 7 and 8 cleanroom capacity.
The company generates revenue through B2B project-based contracts and long-term manufacturing agreements on a quote-based pricing model determined by project scope, volume, materials, and regulatory requirements, with a direct enterprise sales motion targeting OEM procurement and engineering teams and supporting demand generation via medical device industry trade shows (MD&M West, BIOMEDevice, MD&M Minneapolis, Design-2-Part). Seisa's go-to-market emphasizes vertical integration (concept through commercial approval), regulatory expertise (FDA 21 CFR Part 820, ISO 13485, and multiple FDA 510K approvals since 2015), and a configuration management / data syndication platform to accelerate time-to-market for OEM customers. Following three capability-building acquisitions completed in 2019-2021 (Burpee MedSystems, ProtoQuick, and Peridot), Seisa was itself acquired by TekniPlex Healthcare in December 2023 and now operates as a wholly-owned subsidiary within TekniPlex's medical technology solutions platform.
Seisa firmographics
Firmographics- Name
- Seisa
- Legal name
- Seisa Medical
- Website
- https://seisa.com
- Company type
- Private
- Founded year
- 1983
- Operating status
- Operating
- Headcount range
- 1,001–5,000 employees
- Short description
- Seisa Medical is a vertically integrated medical device CDMO providing end-to-end design, FDA 510K regulatory support, and Class II/III contract manufacturing for medical device OEMs in cardiovascular, neurovascular, endovascular, peripheral vascular, dialysis/drug delivery, and orthopedic applications across the US, Mexico, and Slovakia.
- Ownership category
- akta.pro rank
Seisa industry classification
Industry- Product category
- Medical Device Contract Manufacturing
- NAICS
- Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)
- akta.pro primary industry
- Drug Substance–Drug Product Integrated CDMO (HLAGABAG)
- akta.pro secondary industries
- Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Packaging, Labeling & Serialization (Clinical/Commercial) CDMO (HLAGABAJ)
Keywords
Where Seisa is headquartered
LocationHeadquarters
- HQ city
- El Paso
- HQ country
- United States
- HQ region
- North America
Offices5 records
Markets served
Seisa business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain, Marketing or Sales
Revenue model
- Contract Manufacturing Services: Full-service contract manufacturing organization providing design and development, component manufacturing, and final assembly services for medical device OEMs. Revenue is generated through project-based contracts and long-term manufacturing agreements for Class II and Class III medical devices.
- FDA 510K Regulatory Services: Regulatory and compliance solutions including quality management systems, design controls, post-market surveillance, and clinical evidence support for bringing products to market.
- Supply Chain Solutions: Customized supply chain management including inbound and outbound logistics, vertical integration, supplier selection, and vendor management services.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels6 records
Seisa product offering
Product offeringCore offering
Seisa Medical is a global full-service contract development and manufacturing organization (CDMO) providing end-to-end solutions for Class II and Class III medical devices. The company serves medical device OEMs with vertically integrated capabilities spanning product design and development, FDA 510K regulatory support, component manufacturing (injection molding, extrusion, laser cutting, Nitinol processing, CNC machining), final assembly, and supply chain solutions. It operates 150,000 square feet of Class 7 and 8 cleanroom capacity across facilities in the United States, Mexico, and Slovakia.
Product overview
Seisa Medical is a global full-service contract development and manufacturing organization (CDMO) providing end-to-end medical device solutions. The company operates as a vertically integrated platform offering design and development services, regulatory support (including FDA 510k approvals), and comprehensive manufacturing capabilities spanning implantable components, delivery systems, catheter solutions, and specialty alloy processing. The portfolio includes core services such as Product Design & Development, 510k Regulatory Support, Medical Device Prototyping, Testing Capabilities, and Supply Chain Solutions, combined with manufacturing capabilities including Injection Molding, Medical Extrusion, Laser Cutting & Welding, Nitinol and Specialty Alloy Solutions, CNC Machining, Wire Forming, Mold Making, and Catheter Solutions. The company specializes in Class II and Class III FDA-registered medical devices including stents, catheters, guidewires, and pediatric/orthopedic products.
Differentiator
Problem solved
Functional benefit
Products and services
- Product Design & Development Comprehensive design and development services for medical devices including concept-to-completion support, design control following FDA 21 CFR 820.30 and ISO 13485, regulatory filing assistance, and FDA 510K approval processes. Targeted at medical device OEMs building Class II and Class III products.
- 510K Approval & Regulatory Support
- Medical Device Prototyping
- Medical Device Manufacturing
- Implantable Components and Delivery Systems
- Catheter Solutions
- Injection Molding
- Medical Extrusion
- Laser Cutting & Welding
- Nitinol and Specialty Alloy Solutions
- CNC Machining and EDM
- Wire Forming
- Mold Making
- Testing Capabilities
- New Product Introduction
- Supply Chain Solutions
- Collaborative Project Transfers
Quantifiable outcome
- Successfully scaled production output of an implantable device by 50% within four months by recruiting and training more than 5,000 people
- +1 more outcomes
Companies that use Seisa
Customer profileNamed customers1 record
Segments6 records
Ideal customer profiles1 record
Seisa technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Seisa partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- TekniPlex HealthcarecoreTekniPlex Healthcare completed the acquisition of Seisa Medical in December 2023. This acquisition significantly extends TekniPlex Healthcare's medical technology solutions platform, enhancing materials science and process technologies for minimally invasive and interventional therapy devices on a global scale. This is the 21st acquisition TekniPlex has completed in the past decade. Seisa now operates as a subsidiary under TekniPlex Healthcare, becoming a full-fledged CDMO (contract development and manufacturing organization).
Scale indicators8 records
Recent moves7 records
Expansion highlights6 records
Seisa competitors and assessment
Company assessmentDirect peers
- Integer Holdings: Largest pure-play medical device contract manufacturer and outsource partner — directly comparable in providing Class II/III device design, manufacturing, and assembly services to OEM customers in cardiovascular, neuromodulation, and other therapeutic areas.
- Avalign Technologies: Medical device CDMO specializing in implants, instruments, and delivery systems across orthopedics, spine, and surgical applications — direct competitor in precision machining, Nitinol processing, and finished device assembly for OEM customers.
- Tegra Medical: Medical device contract manufacturer focused on metal and plastic components, complex assembly, and finished devices for surgical and interventional OEMs — closely comparable in precision machining and finished device manufacturing.
- Viant Medical: Full-service medical device contract manufacturer offering design, engineering, tooling, injection molding, and assembly — comparable end-to-end OEM service model with similar focus on complex Class II/III finished devices.
- Nordson Medical: Division of Nordson providing medical device component manufacturing including tubing, balloons, and precision components for catheter and delivery-system OEMs — overlapping capability set in catheter-based and minimally invasive device components.
- Donatelle: Medical device contract manufacturer offering injection molding, assembly, and regulatory support for Class II/III OEMs — comparable full-service CDMO model with similar focus on interventional and surgical device programs.
- Cirtec Medical: Medical device CDMO specializing in minimally invasive, implantable, and active implantable devices including neuromodulation and drug delivery — directly comparable in Class III implant and delivery system manufacturing.
Broad incumbents
- Jabil Healthcare: Large global EMS provider with a dedicated Healthcare and Life Sciences division serving medical device OEMs — comparable manufacturing services at scale but operating as a broad multi-industry incumbent rather than a specialized CDMO.
- Flex (Flextronics) Medical: Global contract manufacturer with a medical device business serving OEMs in design, manufacturing, and supply chain — overlapping capability set but as part of a much broader multi-industry manufacturing platform.
Regional players
- Europlaz Technologies: UK-based medical device contract manufacturer offering design, development, and manufacturing services for Class II/III OEMs — comparable service portfolio but primarily serves European customers rather than the US/Mexico market where Seisa is concentrated.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Seisa social profiles
Digital presenceSeisa compliance and trust
Trust signalCompliance2 records
Seisa financial estimates
Financial estimateRevenue estimate
Valuation estimate
Seisa leadership team
Management profileNumber of profiles
Profiles2 records
Seisa subsidiaries and ownership
Company hierarchySubsidiaries3 records
Seisa funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Seisa M&A and investment
M&A and investmentM&A2 records
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Seisa
What does Seisa do?
Seisa Medical is a global full-service contract development and manufacturing organization (CDMO) providing end-to-end solutions for Class II and Class III medical devices. The company serves medical device OEMs with vertically integrated capabilities spanning product design and development, FDA 510K regulatory support, component manufacturing (injection molding, extrusion, laser cutting, Nitinol processing, CNC machining), final assembly, and supply chain solutions. It operates 150,000 square feet of Class 7 and 8 cleanroom capacity across facilities in the United States, Mexico, and Slovakia.
Is Seisa a public or private company?
Seisa is a private company. It is classified as corporate owned and is currently operating.
When was Seisa founded?
Seisa was founded in 1983. It employs 1,001 to 5,000 people.
Where is Seisa based?
Seisa is headquartered in El Paso, United States, in the North America region.
How does Seisa make money?
Three revenue lines are on record. Contract Manufacturing Services are the primary driver. The others are FDA 510K Regulatory Services and supply Chain Solutions.
Who are Seisa's main competitors?
Direct peers on record are Integer Holdings, Avalign Technologies, Tegra Medical, Viant Medical, Nordson Medical, Donatelle and Cirtec Medical. Broad incumbents are Jabil Healthcare and Flex (Flextronics) Medical. Europlaz Technologies is listed as a regional player.
Does Seisa have an API?
No public API is recorded for Seisa.
What industry is Seisa in?
Seisa's product category is Medical Device Contract Manufacturing. Its primary akta.pro industry code is HLAGABAG, Drug Substance–Drug Product Integrated CDMO, with a secondary code of HLAGAKAJ, Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA). Its NAICS code is 339112 and its SIC code is 3841.