Injection Molding For Cosmetic Medical Equipment

ISO13485 Certification and Advanced Capabilities: FCE’s Contribution to Aesthetic Medical Devices

FCE is proud to be ISO13485 certified, a globally recognized standard for quality management systems in medical device manufacturing. This certification underscores our unwavering commitment to meeting the rigorous requirements of medical products, ensuring reliability, traceability, and excellence at every stage of production. With our state-of-the-art Class 100,000 cleanroom and expertise in manufacturing, we are fully equipped to produce high-quality, FDA-compliant medical devices that meet the highest standards of safety and functionality.

Partnering with Like Bio: Aesthetic Device Innovation

Like Bio, a leading company in the field of handheld aesthetic medical devices, sought a manufacturing partner with robust engineering capabilities and ISO13485-certified cleanroom facilities. After careful evaluation, Like Bio identified FCE as the ideal partner for their product development. The initial phase involved refining a 3D model of their device, which required both functional and aesthetic enhancements.

Our team at FCE performed a comprehensive review of the design, offering several optimization suggestions based on our extensive manufacturing experience. Through close collaboration with Like Bio, we successfully balanced the technical and aesthetic requirements, delivering a solution that surpassed their expectations.

Challenges in Custom Color Matching for Medical Applications

One of the key challenges in this project was achieving the precise color requested by Like Bio. The client desired a unique green hue for the device’s exterior. This presented several challenges, including selecting the appropriate medical-grade materials, ensuring accurate color mixing, and maintaining high production yields.

FCE recommended using medical-grade plastic resins combined with food-safe color additives to achieve the desired shade. After producing initial samples, the color was fine-tuned by comparing it to the client’s preferences and standardized color swatches. This meticulous approach resulted in a custom color formulation that perfectly aligned with Like Bio’s vision.

Leveraging DHR for Traceability and Quality Assurance

As part of our ISO13485 compliance, FCE maintains a rigorous Device History Record (DHR) system, documenting every aspect of the manufacturing process. This includes batch numbers, production parameters, and quality control records, ensuring comprehensive traceability. Our DHR system allows us to track production history for up to five years, providing unparalleled accountability and ongoing post-production support.

Long-Term Success Through Collaboration

FCE’s dedication to quality, strict adherence to ISO13485 standards, and ability to overcome complex manufacturing challenges have earned us a strong reputation in the industry. Our partnership with Like Bio has evolved into a long-term collaboration, marked by mutual growth and innovation. Together, we continue to push the boundaries of aesthetic medical device manufacturing, setting new benchmarks for precision, reliability, and client satisfaction.

By combining cutting-edge technology, stringent quality systems, and tailored manufacturing solutions, FCE is proud to lead the way in delivering high-performance medical devices that meet the highest standards in the industry.