Manufacturers of medical devices must follow Good Manufacturing Processes (GMP) to ensure their final products comply with various global regulatory demands. Americhem understands the critical evaluative criteria that medical device manufacturers and molders must meet when it comes to engineering materials. Our ColorRx® pre-colored medical compounds are specially created with precise properties and biocompatible resin technology to achieve exact processing requirements and product expectations. These can include tight color tolerances, specific pigment classifications, low friction surfaces, FDA-compliant ingredients, proven structural integrity and more.
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The color selection of medical products can greatly impact caregiver and patient confidence, ultimately strengthening your brand’s reputation. When considering your medical application, know that major medical device manufacturers around the globe trust Americhem’s medical compounds to reach their color differentiation and color-coding goals.
Working hand in hand with a member of our world-class commercial color team, we’ll start by conducting a thorough interview to determine your exact product needs. These documented answers are used by our chemists to customize an innovative ColorRx® formula in our full-service lab. Color chip samples are then sent to you for approval, along with the defined parameters, to confirm our mutual understanding of all requirements. Americhem’s commitment to personalized service ensures optimized solutions and total responsiveness for our medical plastics customers.
Americhem pledges to its customers a total commitment to product quality and safety. Our team of experts is highly knowledgeable about FDA approvals and clearances of medical products by type. When it is time for your product to be evaluated for FDA status, you can rest assured that our ColorRx® medical compounds have already been tested to meet the latest FDA biocompatibility standards. Using FDA compliant pigments and providing documentation that verifies material analysis, we can help speed time to market.
Today’s modern healthcare systems require medical-grade plastic products that meet rigorous market demands and regulations. Product durability, biocompatibility, weight, performance and cost are important factors to consider when evaluating raw materials. Americhem’s engineered compounds are helping transform the medical marketplace, allowing manufacturers to steadily replace less advantageous materials such as metal and glass with high-performance plastics that outperform any commodity compound on the market.