Custom High-Transparency PMMA/PS IVD Consumables

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.

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.

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.

The booming global in vitro diagnostics (IVD) industry has raised higher standards for high-precision, cleanroom-grade and compliance-based production of IVD disposable consumables. In 2026, professional global exhibitions will fully focus on IVD core consumable precision molds, micro-nano injection molding, clean manufacturing and biocompatible medical materials, becoming core platforms for mold and injection molding enterprises to grasp market trends, upgrade technologies and expand domestic and overseas customers. Core 2026 Global Professional IVD-focused Exhibitions CACLP | Mar 21–23, Xiamen, China The world’s top IVD full-industry-chain exhibition, focusing on IVD dedicated multi-cavity precision molds, injection-molded consumables (pipette tips, 96-well plates, reaction cuvettes) and medical raw materials, ideal for connecting domestic end IVD manufacturers. MedtecLIVE Stuttgart | May 05–07, Stuttgart, Germany Europe’s core medical precision manufacturing event, focusing on ultra-precision molds for microfluidic chips and thin-wall IVD consumable micro-injection molding, supporting EU market expansion and compliance adaptation. ADLM | Jul 26–30, Anaheim, USA Global top clinical diagnostics expo, featuring FDA-compliant IVD injection molding processes, durable dedicated molds and standardized lab consumables for North American business layout. Medtec China | Sep 01–03, Shanghai, China Leading domestic medical manufacturing exhibition, showcasing IVD micro-precision molds, cleanroom injection molding equipment and automated integrated production lines for compliant mass production and yield optimization. Core Industry Development Trends 1. Intelligent & Automated Production: Intelligent customized injection machines and unmanned production lines become mainstream, meeting strict requirements for batch consistency and high-efficiency mass production of IVD consumables. 2. Micro & High-precision Mold Upgrading: Miniaturized, thin-wall and microfluidic IVD products drive the iteration of micro-nano high-precision, corrosion-resistant and long-life dedicated molds. 3. Green & Compliance Manufacturing: Biocompatible and eco-friendly medical materials and low-pollution clean molding processes have become the essential threshold for global high-end order cooperation. Industry Key Takeaways IVD mold and injection molding enterprises need to focus on precision mold R&D and injection process optimization, adapt to miniaturization and compliance trends, and provide one-stop customized solutions to seize global high-quality IVD market opportunities in 2026.