Medical Injection Molding Company in ISO 13485 Cleanrooms in Taiwan | THY Precision
THY Precision Medical Injection Molding Company in Taiwan
Single Use Medical Devices
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ISO 7 & ISO 8 Cleanroom injection molding, assembly & packaging of medical devices
Medical Device OEM
THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with cleanroom injection molding and assembly.
CHANGHUA, TAIWAN, February 16, 2026 /EINPresswire.com/ -- THY Precision (Hong Yang Precision Industry Co., Ltd.) is a Taiwan-based ISO 13485 certified medical device contract manufacturer, continues to strengthen its position as a leading provider of cleanroom medical plastic injection molding services for global medical device OEMs. With advanced manufacturing capabilities, validated cleanroom environments, and a robust quality management system, THY Precision supports customers from early-stage development through high-volume production of medical plastic components, cleanroom assembly and packaging.
As regulatory requirements and quality expectations continue to rise across the medical device industry, THY Precision remains committed to delivering consistent, compliant, and scalable medical injection molding manufacturing solutions. The company specializes in precision plastic injection molding within controlled cleanroom environments, ensuring product safety, traceability, and reliability for critical medical applications.
ISO 13485 Certified Medical Injection Molding Manufacturer in Taiwan
THY Precision operates under a comprehensive ISO 13485 quality management system designed specifically for medical device manufacturing. This certification demonstrates the company’s ability to meet stringent international standards related to risk management, process validation, documentation, and continuous improvement.
By aligning its manufacturing processes with global regulatory expectations, THY Precision enables medical device companies to accelerate market entry while maintaining compliance with regional and international standards.
Compliance with Global Medical Device Standards
THY Precision’s quality system supports customer requirements for FDA, EU MDR, and other international regulatory frameworks. Strict change control, traceability, and validation processes are implemented throughout the product lifecycle.
Robust Quality Management System (QMS)
From incoming material inspection to final product release, every production stage is governed by documented procedures, in-process controls, and inspection protocols to ensure consistent product quality.
Advanced Cleanroom Injection Molding Capabilities
Cleanroom manufacturing is essential for many medical plastic components, particularly those used in diagnostic, surgical, and single use medical devices. THY Precision operates ISO Class 7 and ISO Class 8 cleanroom environments, tailored to customer and product requirements for precision injection molding.
ISO Class 7 & ISO Class 8 Cleanroom Manufacturing
The company’s cleanroom facilities are designed to minimize contamination risks and support stable, repeatable production for sensitive medical components.
Medical-Grade Materials Expertise
THY Precision has extensive experience processing a wide range of medical-grade thermoplastics and elastomers, including PP, PE, ABS, PC, and TPE materials. Material selection and processing parameters are carefully controlled to ensure performance, biocompatibility, and consistency.
High-Precision Plastic Components for Medical Devices
THY Precision focuses on producing high-precision plastic components that meet tight dimensional tolerances and functional requirements. Its manufacturing capabilities support a wide range of medical applications.
Disposable Medical Devices Plastic Injection Molding and Single-Use Medical Device Components
As a medical injection molding company, THY Precision is experienced in producing disposable and single-use medical components, where cleanliness, consistency, and cost efficiency are critical.
Diagnostic, Surgical, and Drug-Delivery Applications
THY Precision supplies plastic components used in diagnostic devices, surgical instruments, and drug delivery, supporting both established products and next-generation medical technologies.
End-to-End Support for Global Plastic Medical Device OEMs
Beyond injection molding, THY Precision provides end-to-end manufacturing support to help customers streamline their supply chains and reduce development risks.
Design for Manufacturability (DFM) & Tooling Development
Early-stage DFM support helps customers optimize part design, material selection, and tooling concepts to improve manufacturability, reduce cost, and shorten development timelines.
Medical Injection Molding Plastic Secondary Processes, Assembly, and Packaging
Additional services include secondary processing, component assembly, and packaging solutions designed to meet cleanroom and customer-specific requirements.
Why Global Customers Choose THY Precision
Medical device companies choose THY Precision not only for its technical capabilities, but also for its long-term partnership approach.
Taiwan-Based Manufacturing with Global Supply Capability
Located in Taiwan, THY Precision offers the advantages of a strong manufacturing ecosystem, skilled engineering talent, and reliable global logistics support.
Stable Quality, Scalable Capacity, and Long-Term Partnership
The company emphasizes stable production quality, scalable manufacturing capacity, and transparent communication, helping customers manage risk and plan for long-term growth.
About THY Precision
THY Precision (Hong Yang Precision Industry Co., Ltd.) is an ISO 13485-certified medical plastic injection molding company based in Taiwan. Specializing in cleanroom manufacturing, the company provides high-precision plastic components for medical devices, diagnostics, and single-use applications. With a focus on quality, regulatory compliance, and customer collaboration, THY Precision supports global medical device OEMs from design and tooling through mass production.
Core Capabilities
✅ High-Precision Injection Molding
• Over 80 FANUC all-electric injection molding machines with robotic arms
• Semi-automatic & fully automatic high-volume production
• Tolerance capability ±0.001 mm
• Specialized in thin-wall, micro-sized, and complex geometry parts
✅ In-House Tooling & Mold Fabrication
• Full-service in-house tooling for high-precision mold development
• Fast turnaround for mass production
✅ Clean Room Manufacturing
• ISO Class 8 cleanroom (13,000 sq.ft) for cleanroom injection molding
• ISO Class 7 cleanroom (7,500 sq.ft) for cleanroom assembly and packaging
• Ideal for medical plastic components manufacturing, single-use medical devices, and biocompatible products
• Core capability in clean room manufacturing for sensitive industries
✅ Advanced Injection Molding Technologies
• Expert in medical molding, micro molding, and high-temperature plastic processing
• Materials include medical-grade plastics like PEEK, PC, PP
• Precision molding solutions for medical, optical, and electronics sectors
✅ 24/7 Automated Production
• Continuous, round-the-clock production schedule for fast lead times and efficient manufacturing
• Automated handling ensures repeatability and reliability
✅ Comprehensive Quality Assurance
• CMM, 2.5D vision systems, and full traceability throughout production
• Ensures compliance with ISO 13485 standards for medical devices
✅ OEM & CDMO Turnkey Services
• One-stop medical device OEM and CDMO solution provider
• Services include DFM support, mold development, cleanroom molding, assembly, packaging, and regulatory documentation
• Trusted medical device contract manufacturer with scalable production for Class I & II & III devices
THY Precision stands at the forefront of medical plastic injection molding companies in Taiwan, combining engineering expertise, clean room capabilities, and scalable manufacturing. Whether you're seeking a medical device OEM, medical plastic components manufacturing partner, or a full-service plastic injection molding company, we deliver performance, precision, and reliability. Please visit https://www.thy-precision.com for details information.
ADDRESS:
No. 9, Chanxue 4th., Rd., Erlin Township,
Changhua County, 526016, Taiwan
https://www.thy-precision.com
Sharon Kao
Hong Yang Precision Industry Co., Ltd.
sales@thy-precision.com
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Medical Injection Molding Company with Automated Manufacturing in Taiwan
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