About
Founded in 1990 by German-American engineer Will Zeigner and his Taiwanese wife Sara Chow, ZMI originally produced automotive cruise control devices. Over time, leveraging its engineering expertise, ZMI transitioned into a comprehensive OEM/ODM supplier of medical devices and accessories for global healthcare brands.
We focus on the research, design, manufacturing, and support of medical equipment and accessories, including electrotherapy, phototherapy, sonotherapy, diathermy, and traction therapy devices, serving applications in neurology, rehabilitation, orthopedics, otolaryngology, homecare, and personalized medicine.
Our full-service solutions cover the entire product lifecycle, from concept design to manufacturing, including product validation, international certification support, and customized development.
With extensive experience in global regulatory compliance and quality assurance, ZMI is a trusted partner for medical companies worldwide, and welcomes collaboration with established brands, startups, and investors to develop innovative medical solutions.
Milestone
| Year | History |
|---|---|
| 2023 | Launched a brand new Levina Wireless Muscle Stimulator and obtained the premarket clearance from US FDA and Taiwan FDA. The new product line is undergoing official MDR review. |
| 2022 | Registered and moved the headquarters to Kaohsiung Software Park (managed by Ministry of Economic Affairs) and expanded the production capacity at the factory site. |
| 2021 | Obtained SRN from EUDAMED database under the new MDR compliance. Established a ISO 14644 certified ISO 8 (class 100,000) cleanroom in house for single use / reusable sterile and intra-cavity / body orifice medical accessories. |
| 2020 | Comprehensively introduced medical accessory products for human-machine collaboration. Collaborated with Changhua Shiuchuan Memorial Hospital to release postoperative deep vein thrombosis prevention products. |
| 2019 | Obtained MDSAP single audit plan quality system certification. Helped customers with multi-national product certificate transfer, technical document management and production registration. |
| 2018 | Obtained ISO 13485:2016 certification and introduced CRM platform services to customers to instantly access the critical info online. Implemented the first collaborative robotic arm in the manufacturing line to increase the proportion of automated processes. |
| 2017 | Developed the semiconductor-based shortwave diathermy modules for European and US customers, and developed the non-hotspot self-adhesive electrode technology. |
| 2014 | Accelerated internal digitalization and built an internal management system platform to implement data management. Cooperated with US customers to develop wearable electrotherapy and phototherapy devices, officially entered the wearable and consumer-based medical market. |
| 2013 | Developed the first app-based product (Smart Handle) for the sport medicine market. Entered the field of mobile app-based medical products. |
| 2011 | Yuta Lee took over the company as the third generation leader, and led the company into the high-end rehabilitation market, and introduced digital, BSC management tools and TPS Toyota lean production management. |
| 2010 | Developed spinal decompression traction equipment for US rehabilitation brands and assisted customer in obtaining FDA and CE certifications. |
| 2008 | Developed high-potential therapeutic products for domestic customers and obtained TFDA certification. |
| 2007 | Implemented CMDCAS quality management system for Canada Market. Developed industrial ultrasonic products and high-power RF module products. |
| 2003 | Expanded R&D team focusing on the application of electrotherapy, phototherapy and ultrasound as core technologies. Implemented ERP information management tool for the company. |
| 2001 | Lee family took over the company, Paul Lee took over as the second-generation leader. Introduced ISO 13485 and GMP quality management system for the company and developed the OEM business for the US rehabilitation market. |
| 1997 | Developed the first electrotherapy vacuum suction device and rubber electrodes for the European customers. |
| 1995 | Officially entered the medical device industry. |
| 1990 | Company founded by Will Zeigner & Sara Chow mainly producing the automotive constant speed controllers. |
ZMI operates with a team-based approach, ensuring every employee contributes to customer satisfaction and service excellence. From product design and procurement to manufacturing, assembly, and delivery, we provide end-to-end expertise across all stages of production. Our goal is to deliver the highest value with uncompromised quality.
As a dedicated OEM/ODM manufacturer, ZMI does not own proprietary brands—our customers retain full ownership of their designs and patents. With state-of-the-art equipment and rigorous processes, we transform concepts into high-quality products, from prototype to mass production, tailored to exact requirements.
Our engineering team brings extensive experience in electronic system design, CAD PCB layout, and product validation. This technical strength allows us to provide fast turnaround for pre-production units and engineering prototypes, while ensuring compliance with international standards.
ZMI is committed to developing innovative rehabilitation and medical equipment that improves the quality of life for patients worldwide. As societies face aging populations, our reliable, user-friendly solutions empower medical professionals and enhance patient well-being.
Our Commitment
At ZMI Electronics, we are dedicated to providing comprehensive OEM and ODM solutions, ensuring customer satisfaction through innovation, quality, and reliability.
Vision
To be a trusted partner for global medical device companies, delivering quality and innovative manufacturing solutions that enhance patient care.
Mission
To provide end-to-end support from product design and development to manufacturing and delivery, with a strong focus on quality, service, and long-term partnerships.
Philosophy
- Respect
- Cooperation
- Improvement
Internally, ZMI values the unique strengths of each team member and fosters open, collaborative communication to achieve both individual and company-wide growth. Externally, we approach long-term partners—whether suppliers or clients—with respect, leveraging each party’s expertise to collaboratively develop production, enabling the entire supply chain to thrive in a competitive environment.
Registration & Compliance
- CE (EUDAMED SRN: TW-MF-000003571, NB2460 DNV)
- Health Canada MDL (ID:124828)
- US FDA Registration (ID:9617486)
- Taiwan FDA GMP (ID:GMP0233)
Factory Highlights
- 1,700m² facility (18,300ft²)
- ISO 14644 Class 8 cleanroom
- Robotic arms & CNC machining
- RF testers & IP67 waterproof test system
- Laser engravers & industrial microscopes
Certificates
CE-2460
ISO13485
GMP/QSD
Top Medical Device Manufacturer in Taiwan - Custom Solutions
ZMI provides OEM and ODM medical devices, offering high-quality electrotherapy, phototherapy, sonotherapy, hyperthermia, and force therapy equipment. Our solutions also include Medical Electrodes, Medical Leadwires, wireless TENS and EMS units, widely used in physical therapy, rehabilitation, neurology, orthopedics, and homecare.