About
ZMI (Zeigner Manufacturing Industry) was founded by a German American, Will Zeigner, and his Taiwanese wife Sara Chow. Early ZMI mainly produced automotive constant speed controller. After several years, the company transformed into a medical device and accessory supplier, focusing on OEM / ODM service for world leading medical device brands.
ZMI continues to dedicate efforts on the research and development, design, manufacture and support of equipment and accessories for the following fields: electrotherapy, photontherapy, sonotherapy, diathermy, traction therapy and other equipment and accessories commonly used in physical therapy. The clinical applications cover neurology, rehabilitation, orthopedics, otolaryngology, homecare and personalized medicine. ZMI has provided comprehensive services from product development to the manufacturing, providing complete product validation, and other professional services for medical device certification in various countries.
| 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 under the official MDR review process. |
| 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 | Comprehensive introduction of medical accessories products for human-machine collaboration. Cooperated with Changhua Shiuchuan Memorial Hospital and released 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 obtains 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, was engaged as the second generation leader. Introdcued ISO 13485 and GMP quality management system for the company and developed the OEM business for the US rehabilitation market. |
| 1997 | Developed the first electrothearpy vacuum suction device and rubber electrodes for the European customers. |
| 1995 | Officially transformed the business industry into medical device. |
| 1990 | Company founded by Will Ziegner & Sara Chu mainly producing the automotive constant speed controller. |
The company operates in a team-based manner, enabling each employee to focus on overall customer satisfaction and service. From development/design and procurement to manufacturing, assembly and delivery, we have excellent expertise in all aspects of production. We aim to provide the most comprehensive service with a focus on customer satisfaction and the highest value.
As an OEM / ODM manufacturer, ZMI does not own proprietary brands. Our customers have ownership of custom engineering including patents. State-of-the-art equipment ensures the quality of the product from prototype to production and is manufactured to your exact requirements.
ZMI provides complete technical support for your product. For our customers, the in-depth experience of our engineering team is a vital asset. We are experts in a wide range of applications, including advanced electronic system design and CAD printed circuit board layout. Our diverse capabilities and expertise ensure rapid turnaround of pre-production units and engineering prototypes.
ZMI continues to develop innovative design and production of excellent rehabilitation medical equipment, in addition to allowing medical professionals to use the very convenient and stable quality of reconstructed medical products, and then gradually enter the aging society in Taiwan and other countries in the world. It can also provide quality services for rehabilitation medical care, enabling users who need rehabilitation to have better quality of life and enhance life value.
Becoming a world-class medical professional service provider with various medical and electronic technologies as the core technology for the design and manufacture of hospitals.
Design and manufacture high-quality medical products to effectively alleviate the suffering of patients and achieve the medical merits of all employees.
Respect - Cooperation - Improvement
In the enterprise, the specialists pay special attention to the advantages of different personnel, and then communicate and cooperate with an open-minded attitude to pursue mutual progress and growth with each other.
On the other hand, outside the company, regardless of whether we have been working with suppliers or sales customers for a decade or two, ZMI is also respectful and confronts each other with different perspectives on the event, and then seeks to be good at each other. The advantages of the cooperation to develop production, so that the upstream and downstream supply chain can work together in this competitive environment, and pursue common progress.
EUDAMED CE (SRN: TW-MF-000003571 NB2460 DNV)
Health Canada MDL (ID:124828)
US FDA Registration (ID:9617486)
Taiwan FDA Registration (ID:GMP0233)
• Factory site size 1700m² (18,300ft²)
• Production equipment (cooperative robotic arms, RF test equipment network and spectrum analyzers, comprehensive safety tester, environmental test and reliability test equipment, CNC machine tool, IP67 waterproof level test equipment, CNC vertical injection Machine, laser engraving machine, industrial microscope, etc.
CE-2460
ISO13485
GMP/QSD
