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  • Building 29, Mashantou Community, Third Industrial Zone, Matian Street, Guangming District, Shenzhen, Guangdong, China

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  • One-stop Injection Mold & Molding Services
Precision Plastic Housing Injection Mold

Precision Plastic Housing Injection Mold

Custom cavity structure for housing molds with stable precision.
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Core Pulling Mold

Core Pulling Mold

Designed for complex undercut plastic structural parts.
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High Transparent IVD Consumables Mold

High Transparent IVD Consumables Mold

Optical mirror cavity, surface finish up to Ra 0.008μm.
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Semi-Transparent IVD Consumables Mold

Semi-Transparent IVD Consumables Mold

High-precision cavity for PP translucent medical supplies.
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DisposableMulti-Well Culture Dishes Mold

DisposableMulti-Well Culture Dishes Mold

Multi-cavity integrated design, high-precision positioning.
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Latest Case

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4

For a medical consumables client, the chemiluminescence reaction cups supplied by the original manufacturer suffered from long-term issues including substandard surface polishing, insufficient cleanliness and unstable precision dimensions. Defective products led to a low yield rate, impaired the accuracy of downstream experimental detection, hindered mass production progress, and failed to meet industrial compliance standards. After multi-party comparison and industry recommendation, the client selected our company for cooperation. Supported by years of experience in precision mold development and dust-free injection molding, we conducted a comprehensive analysis on existing defects. Optimizations were made in mold structure, surface treatment and production control to resolve quality problems. All inherent quality defects were fully eliminated. Stable product performance, improved yield and standardized mass production were achieved, steadily meeting the high cleanliness and high-precision requirements of medical chemiluminescence applications.

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The client is a fast-growing medical consumables enterprise trapped in a supply chain dilemma. Large upstream manufacturers have solid capacity but rigid operations and tight production schedules. They respond slowly to customized adjustments, urgent orders and small-batch iterations, restricting the client’s development. Small workshops feature flexible communication and delivery, yet lack standardized management, complete quality control, traceability and medical compliance systems. They cannot meet strict dust-free production and audit standards, posing major compliance risks. Referred by industry peers, the client chose our cooperation. We fully meet the core needs of growing medical enterprises. With ISO management, dust-free workshops and full quality traceability, we satisfy high medical production requirements. Meanwhile, we offer flexible scheduling, stable lead time and high collaboration to support R&D, order changes and urgent mass production. We provide reliable custom mold and injection molding production with strict quality control. Complete audit materials, traceability records and compliance documents are supplied to help the client pass audits and secure compliance. Through long-term partnership, the client has expanded rapidly and built a new industrial base. We are honored to grow together and become their reliable core strategic partner.

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The client, deeply entrenched in the industrial products sector, is urgently seeking a high-quality supplier capable of providing both custom mold fabrication and mass injection molding production. Its structurally complex industrial products required high-precision molding, yet the client’s former suppliers lacked advanced technology and sufficient capacity. Unable to resolve complex molding challenges and meet mass delivery demands, the client faced stalled R&D progress and missed market opportunities due to unstable processes and constant delivery delays. Amid tight project timelines, the client chose us after rigorous industry evaluations. Leveraging our profound precision mold expertise and one-stop supply chain system, we optimized tailored processes for complex product structures and streamlined the full workflow from mold design and sample testing to mass production. With strict full-process quality and production control, we effectively shortened lead times and guaranteed consistent product quality. We delivered premium industrial plastic components on schedule, fully resolving the client’s core issues: complex structure molding difficulties, mold-production disconnection and unmet urgent delivery needs. Our integrated customized production accelerated the client’s new product launch and helped them capture key market opportunities swiftly.

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About Us

OEM Custom Manufacturing

Rayboen is based in Shenzhen, China. Specializing in OEM custom medical precision plastic products, we bring 25 years of industry expertise to deliver stable, high-quality solutions for customers worldwide. We offer end-to-end services including custom precision plastic injection mold development, DFM manufacturability analysis, mold fabrication, cleanroom injection molding and product assembly. Our core products cover IVD plastic components, medical device housings and parts, medical-grade plastic components, engineering plastic parts, plastic structural components and enclosures. Parts can be molded in medical cleanroom environments. We also provide secondary processing and testing such as ultrasonic welding and leak testing, enabling a full closed-loop service from mold development to finished product delivery.

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25+

EXPERIENCE

50+

EMPLOYEE

60+

EQUIPMENT

4000+

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13485
28 , August

Rayboen Achieves ISO 13485:2016 Medical Device Quality Management System Certification

We are proud to announce that Rayboen has officially obtained ISO 13485:2016 Medical Device Quality Management System Certification. This milestone represents our continued progress in precision medical manufacturing, bringing our quality system in line with global medical standards. What is ISO 13485? ISO 13485 is the worldwide quality standard created specifically for medical device manufacturers. Unlike generic quality standards, it enforces strict requirements for standardized production, risk management, full traceability and consistent quality. It serves as the key benchmark to assess a medical manufacturer’s professionalism and compliance. Rayboen delivers one-stop custom solutions for precision medical plastic components and injection molds. Covering DFM analysis, mold design, fabrication, injection molding and final shipment, every step follows medical-grade specifications to ensure stable, compliant outputs. What does ISO 13485 certification mean for us? This is far more than a certificate. It is third-party validation that our daily operations meet international medical manufacturing requirements. We integrate risk assessment, process records and quality checks into real production rather than just paperwork. The audit proves our procedures, documents and on-site controls are fully compliant, enabling us to reliably support global medical device projects. More reliable guarantees for our customers For our partners, ISO 13485 brings real confidence in cooperation. When you work with Rayboen, your medical molds and plastic parts are produced within a controlled medical-grade system, with complete traceability of production and inspection records. The ISO 13485 certification marks a new starting point for our quality management. Moving forward, Rayboen will keep applying medical manufacturing standards, refining our processes and quality controls, and supplying global customers with stable, reliable and compliant precision molds and plastic components.
9001
5 , May

Rayboen Successfully Passed ISO9001 Annual Review

Rayboen has officially passed the annual audit of the ISO9001 Quality Management System, confirming that the company’s quality management, standardized processes and service management fully comply with international quality standards. The annual review covered the full business process, including order management, R&D, production, quality inspection and after-sales service. With strict assessment on quality control, risk management, customer response and continuous improvement, the audit fully recognized Rayboen’s stable and reliable management capabilities. As a globally recognized quality benchmark, ISO9001 underpins Rayboen’s consistent high-standard quality philosophy. This successful annual review ensures standardized, controllable and traceable operations, guaranteeing stable product quality and reliable delivery. Moving forward, Rayboen will continue to optimize its management system, upgrade refined and scientific management, and always provide customers with trustworthy products and professional services.
Rayboen Launches ISO 13485:2016 Certification Process | Medical Injection Molding Manufacturer
21 , April

Rayboen Launches ISO 13485:2016 Certification Process | Medical Injection Molding Manufacturer

April 21, 2026 — Rayboen successfully held the kick-off meeting for the ISO 13485:2016 Medical Device Quality Management System Certification Project. Attended by the company’s senior management team, department leaders and key core employees, the meeting marks a pivotal step forward for Rayboen in medical compliance, quality control and global development strategy. Key Highlights of the Meeting The meeting officially announced the full implementation of the ISO 13485:2016 international standard, aiming to establish a professional medical device quality management system that covers the entire process: design and development, procurement and supply, production and manufacturing, quality control, packaging and delivery, as well as after-sales service. The meeting clarified project goals, implementation plans, role division and schedule milestones. It emphasized taking risk management as the core, regulatory compliance as the bottom line, and quality as the top priority, integrating system requirements into daily operations in depth to ensure product safety, efficacy and traceability. The launch of this certification not only realizes a systematic upgrade of the existing quality management system, but also serves as a strategic layout for the company to deepen its footprint in the medical industry and expand global business. About ISO 13485:2016 ISO 13485:2016 is a dedicated quality management system standard for the medical device industry issued by the International Organization for Standardization (ISO). It focuses on regulatory compliance, risk management and full life cycle quality control, and is widely applicable to enterprises engaged in the design, production and service of medical devices, supporting components and consumables. This standard has become the core market access requirement and credibility benchmark for global regulatory authorities including EU MDR, US FDA QSR and China NMPA, as well as international customers worldwide. The initiation of ISO 13485:2016 certification is an important milestone in the company’s development. In the future, Rayboen will take the system establishment as an opportunity to continuously optimize processes, strictly control product quality and strengthen compliance management. The company strives to obtain the certification as soon as possible, repay customers with higher-standard products and services, and contribute to the development of the global healthcare industry.
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