FCE is proud to be certified under ISO13485, the globally recognized standard for quality management systems in medical device manufacturing. This certification reflects our commitment to meeting the stringent requirements for medical products, ensuring reliability, traceability, and excellence in every process. Coupled with our state-of-the-art Class 100,000 cleanroom, we have the infrastructure and expertise to produce products that meet the highest standards of safety and functionality, including compliance with FDA requirements.
Partnering with Like Bio: Aesthetic Device Innovation
Like Bio, a company specializing in handheld aesthetic medical devices, sought a supplier with strong engineering and development capabilities as well as ISO13485-certified cleanroom facilities. Early in their search, they identified FCE as the ideal partner. Like Bio initially provided a 3D model of their device, which required both functional and aesthetic refinements.
FCE conducted a comprehensive review of the design and proposed multiple optimizations based on our extensive manufacturing experience. Balancing technical functionality and aesthetic requirements, we collaborated closely with the client through several iterations, eventually finalizing a solution that exceeded their expectations.
Challenges in Custom Color Matching for Medical Applications
Given the aesthetic nature of the product, Like Bio requested green as the primary color. Achieving this required overcoming significant challenges, including selecting suitable materials, ensuring precise color mixing, and maintaining high production yields.
FCE recommended medical-grade plastic resins combined with food-safe color additives to achieve the desired result. After producing initial samples, the color was fine-tuned through comparisons with the client’s subjective preferences and standardized color swatches. This rigorous approach resulted in a custom color formulationthat perfectly met the client’s expectations.
Leveraging DHR for Traceability and Quality Assurance
ISO13485 compliance requires meticulous documentation and traceability throughout the manufacturing process. At FCE, we adhere to a robust Device History Record (DHR) management system, documenting every aspect of production, including batch numbers, parameters, and quality control records. This enables us to trace production records for up to five years, ensuring unparalleled accountability and post-production support.
Long-Term Success Through Collaboration
FCE’s dedication to quality, strict adherence to ISO13485 standards, and ability to solve complex manufacturing challenges have earned us a stellar reputation. Our partnership with Like Bio has evolved into a long-term collaboration, with both companies benefiting from shared growth and innovation.
By combining advanced technology, rigorous quality systems, and tailored solutions, FCE continues to set the benchmark for precision and reliability in the medical device manufacturing industry.
Post time: Nov-28-2024