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Top 10 Medical Injection Mold Companies in the World | ||||
Company | Location | Founded | Certifications | Strengths |
Phillips-Medisize | USA / Global | 1964 | ISO 13485, ISO 9001, FDA, MDSAP | Global CDMO, advanced molding, regulatory expertise |
SMC Ltd. | USA / Global | 1988 | ISO 13485, FDA registered | Integrated, Class 7/8 cleanrooms, micro & silicone molding |
Alpine Mold | Shenzhen, China | 2002 | ISO 13485, ISO 9001 | Medical injection mold supplier & medical injection molder, ±0.01 mm precision |
Viant Medical | USA / Global | 1965 | ISO 13485, ISO 14971, FDA | Bridge tooling, cleanroom assembly, full device manufacturing |
Tessy Plastics | USA / China | 1973 | ISO 13485, FDA, ISO 9001 | Large cleanroom facilities, automation |
Accumold | USA | 1985 | ISO 13485, ISO 9001 | Micro molding specialist, Class 7/8 cleanrooms |
Spectrum Plastics | USA / Global | 1949 | ISO 13485, ISO 9001, AS9100; | Advanced materials, global footprint |
Nolato MediTech | Sweden / Global | 1938 | ISO 13485, ISO 9001, ISO 14001; | Multi-material molding, silicone & thermoplastic |
Jabil Healthcare | USA / Global | 1966 | ISO 13485, FDA; | Automation, supply chain management |
Westfall Technik | USA | 2017 | ISO 13485, ISO 9001 | Cleanroom molding, automation, innovation |
Medical devices demand the highest levels of precision, quality, and regulatory compliance. From diagnostic components to implantable housings, every plastic part must meet stringent standards such as ISO 13485, FDA 21 CFR, and EU MDR. That is why selecting the right partner from the world’s Top Medical Injection Mold Companies is essential for OEMs, product designers, and procurement teams.
In this article, we present the Top 10 Medical Injection Mold Companies in the World, each with proven expertise in mold design, tooling, and cleanroom injection molding. These companies combine engineering know-how with robust quality systems to deliver reliable, high-performance medical components for global healthcare manufacturers.
Website: https://phillipsmedisize.com
Location: Global HQ in Hudson, Wisconsin, USA; facilities in North America, Europe, Asia
Founded: 1964
Certifications: ISO 13485, ISO 9001, FDA-registered facilities, MDSAP
Main Services: Advanced injection molding, drug-device combination products, design & development, automation, cleanroom molding, assembly
Industries: Medical devices, diagnostics, drug delivery, consumer health
Company Introduction:
Phillips-Medisize, part of Molex, is one of the Top Injection Mold Companies for Medical Devices. With more than five decades of experience, it provides end-to-end services from design and development to large-scale cleanroom manufacturing. The company specializes in advanced molding technologies such as liquid silicone rubber (LSR), multi-material injection molding, and micro-molding. Its global footprint ensures consistent quality across multiple regions, supporting rapid product transfer and regulatory compliance for the world’s leading healthcare brands.
Website: https://smcltd.com
Location: Headquartered in Wisconsin, USA; facilities in the US, Europe, Asia, and India
Founded: 1988
Certifications: ISO 13485, FDA registered, Part 4, MedAccred, cGMP/QSR compliant
Main Services: Medical injection molding, tool building, micro molding, silicone molding, contract manufacturing, cleanroom assembly
Industries: MedTech, diagnostics, drug delivery systems, minimally invasive devices
Company Introduction:
SMC Ltd. is a global Medical Injection Mold Company recognized for its vertically integrated services. All facilities are FDA-registered and ISO 13485 certified, with Class 7 and Class 8 cleanrooms for molding and assembly. The company provides complete solutions including tooling, high-volume molding, and automated assembly lines. With its global network, SMC supports major OEMs in scaling medical innovations to commercial production while meeting the strictest quality and regulatory requirements.
Website: https://alpine-mold.com
Location: Shenzhen, China
Founded: 2002
Certifications: ISO 13485, ISO 9001
Main Services: Custom mold design, medical injection molding, rapid prototyping, DFM & Moldflow analysis, tool making, low/high volume molding
Industries: Medical devices
Company Introduction:
Alpine Mold is recognized as one of the leading Medical Injection Mold Companies in Asia. With over 23 years of experience and more than 10,000 completed projects, the company specializes in precision medical mold making and injection molding solutions. Its services cover the entire process—from prototyping, mold design, and mold making to cleanroom molding. With machining accuracy down to ±0.01 mm, Alpine Mold supports medical OEMs in developing diagnostic devices, disposable consumables, and complex housings. Known for fast lead times, cost efficiency, and strong engineering support, Alpine Mold is a reliable partner for international healthcare manufacturers.
4. Viant Medical
Website: https://viantmedical.com
Location: Headquarters in Foxborough, Massachusetts, USA; operations across the US, Mexico, Costa Rica, Europe, and China
Founded: 1965
Certifications: ISO 13485, ISO 14971, FDA-registered sites
Main Services: Medical-grade plastics molding, micro molding, precision tooling, cleanroom injection molding, device assembly, packaging
Industries: Surgical devices, diagnostics, drug delivery systems, interventional products
Company Introduction:
Viant Medical is a global contract manufacturer providing design, development, molding, and finished device assembly. Its molding capabilities include complex micro components, thermoplastics, and silicones. With Class 7 and Class 8 cleanrooms, Viant ensures strict contamination control for critical devices. The company is known for its rapid prototyping and “bridge tooling” solutions that allow OEMs to accelerate clinical trials. Viant is trusted by major medical brands for its ability to handle complex, high-risk projects.
5. Tessy Plastics
Website: https://tessy.com
Location: Elbridge, New York, USA; operations in USA and China
Founded: 1973
Certifications: ISO 13485, ISO 9001, FDA registered, ISO 14001
Main Services: Precision mold making, medical injection molding, automation, cleanroom molding and assembly
Industries: Medical devices, diagnostics, consumer products
Company Introduction:
Tessy Plastics is a family-owned business that has become one of the largest privately held Medical Injection Mold Companies in the USA. Its vertically integrated services include design, mold building, high-volume injection molding, and automated assembly. Tessy operates multiple Class 7 and Class 8 cleanrooms for molding and assembly, making it a reliable partner for medical device manufacturers that require full compliance with FDA and ISO standards.
6. Accumold
Website: https://accu-mold.com
Location: Ankeny, Iowa, USA
Founded: 1985
Certifications: ISO 13485, ISO 9001, ISO 14001
Main Services: Micro molding, insert molding, cleanroom molding, precision mold design
Industries: Medical devices, electronics, micro-optics, microfluidics
Company Introduction:
Accumold is a global leader in micro medical injection molding. The company specializes in tiny, highly precise parts for medical diagnostics, surgical instruments, and implantable devices. With decades of experience, Accumold operates Class 7 and 8 cleanrooms and provides rapid prototyping and high-volume production. Its micro molding expertise makes it the partner of choice for OEMs developing next-generation miniaturized medical devices.
7. Spectrum Plastics Group
Website: https://spectrumplastics.com
Location: Alpharetta, Georgia, USA; multiple facilities in North America, Europe, Asia
Founded: 1949
Certifications: ISO 13485, ISO 9001, AS9100
Main Services: Injection molding, extrusion, medical tubing, cleanroom molding, assembly, packaging
Industries: Medical devices, interventional therapies, diagnostics
Company Introduction:
Spectrum Plastics Group offers a broad portfolio of capabilities for medical device manufacturing. Its injection molding services are supported by extensive cleanroom facilities, tool shops, and assembly lines. Spectrum works with advanced materials such as PEEK, polysulfone, and bioresorbable polymers, making it a key partner for complex interventional and diagnostic products. With its global footprint, Spectrum ensures consistent quality for major OEMs across different markets.
8. Nolato (Nolato MediTech)
Website: https://nolato.com
Location: Torekov, Sweden; operations across Europe, USA, and Asia
Founded: 1938
Certifications: ISO 13485, ISO 9001, ISO 14001
Main Services: Injection molding, silicone molding, 2K/3K molding, cleanroom production, tool building
Industries: Medical devices, diagnostics, pharma, telecom
Company Introduction:
Nolato MediTech is a division of the Swedish Nolato Group, focusing on medical device manufacturing. With Class 7 and 8 cleanrooms, Nolato provides high-quality injection molding of thermoplastics and liquid silicone rubber. The company specializes in multi-component molding (2K/3K) and serves global medical OEMs with advanced molding solutions, strong sustainability practices, and full regulatory compliance.
9. Jabil Healthcare (Nypro Legacy)
Website: https://jabil.com/healthcare
Location: St. Petersburg, Florida, USA; 25+ healthcare manufacturing sites globally
Founded: 1966
Certifications: ISO 13485, FDA-registered facilities
Main Services: Injection molding, cleanroom molding, tool building, automation, device assembly, supply chain solutions
Industries: Medical devices, diagnostics, pharmaceutical delivery systems
Company Introduction:
Jabil Healthcare, formerly Nypro, is one of the world’s largest healthcare contract manufacturers. With over 25 ISO 13485 certified sites worldwide, Jabil provides advanced injection molding, automation, and finished device assembly. The company supports global OEMs with regulatory expertise, large-scale manufacturing, and supply chain management. Jabil is trusted by many of the top medical brands for complex, high-volume products.
10. Westfall Technik
Website: https://westfalltechnik.com
Location: Las Vegas, Nevada, USA; multiple sites across the US
Founded: 2017 (rapidly growing through acquisitions)
Certifications: ISO 13485, ISO 9001
Main Services: Custom mold design, medical injection molding, cleanroom molding, automation, contract manufacturing
Industries: Medical devices, consumer goods, packaging
Company Introduction:
Westfall Technik is a fast-growing Medical Injection Mold Company built through the consolidation of several specialized plastics companies. Its facilities include Class 7 and 8 cleanrooms for molding and assembly. Westfall offers advanced automation, rapid prototyping, and high-volume molding. Despite its relatively young age, the company has quickly become a trusted supplier to medical OEMs thanks to its innovative approach and strong focus on quality.
Conclusion
Medical device manufacturing requires more than just medical plastic injection mold and medical injection molded parts—it requires strict quality systems, regulatory compliance, and engineering excellence. The Top 10 Medical Injection Mold Companies in the World listed above represent the best in the industry, each bringing unique strengths:
Phillips-Medisize, SMC, Viant, Jabil, and Spectrum provide large-scale, global capabilities for high-volume, regulated products.
Accumold and Nolato offer specialized expertise in micro molding and multi-material solutions.
Tessy and Westfall deliver strong cleanroom molding and automation for demanding clients.
Alpine Mold stands out as a competitive international partner, combining precision engineering, cost-effectiveness, and rapid response—ideal for OEMs seeking both high quality and efficiency.
Whether you are developing diagnostic consumables, drug delivery devices, or surgical components, choosing the right Medical Injection Mold Company is essential to ensure reliability, scalability, and compliance. Contact us today to get a quote.
