Professional medical device parts manufacturer
High precision, dust-free manufacturing environment, and full compliance with ISO 13485 standards, providing a complete traceability system.
Shin-Yao, having cultivated expertise in the precision plastic products manufacturing field for many years, is committed to the research and development and production of high-quality, high-precision medical key components. We deeply understand the extreme demands of the medical industry for product safety and quality; therefore, we demonstrate profound technical expertise and rigorous craftsmanship in every stage of production.
We strictly adhere to the ISO 13485 medical device quality management system. This ensures that every step, from raw material procurement and production processes to final testing, meets the highest international medical regulatory standards.
What is Medical Grade Platinum-Cured Silicone？
Medical Grade Platinum-Cured Silicone Is a high-purity material specifically designed for harsh medical environments. Using expensive platinum as a catalyst, it ensures that the curing process produces no toxins or odors, and possesses excellent biocompatibility and chemical stability. This material not only withstands repeated high-temperature and high-pressure sterilization, but also boasts excellent tear resistance and clarity, allowing for safe long-term contact with human tissue or medications. It is the preferred top-tier raw material for manufacturing blood transfusion catheters, artificial implants, and precision surgical consumables, perfectly safeguarding patient safety.
Do you want your medical products to be manufactured in a cleanroom？
Our partners have professional cleanrooms and dust-free facilities, and strictly adhere to ISO 13485 certification, ensuring that all processes, from raw material control to shipment, meet your requirements.