Engineered resins are allowing the medical industry device and equipment manufacturers to be more creative with new products. Supporting injection-molding companies offer relationships to create your next product idea and have connections to vendors that provide quality materials and resources. SEA-LECT Plastics, a top-tier manufacturer, produces products in a world-class facility that has earned the Federal Drug Administration (FDA) registration and ISO 13485 certification.
Is SEA-LECT Plastics FDA Registered?
SEA-LECT Plastics is registered with the FDA to produce parts and products for the medical industry. Registering with the Federal Drug Administration to produce medical grade equipment and products requires that the manufacturing facility has a Quality Management System established. SEA-LECT Plastics has a rigorous quality initiative for day-to-day operations, which was recognized during our ISO 9001: 2015 certification. The guidelines are covered under the 21 code of Federal Regulation Part 820 (covering Medical Devices) and cover components that are distributed to a finished device manufacturer or devices and components that are packaged or labeled for commercial distribution of health-related purposes for an end consumer.
Why does SEA-LECT Plastics have an ISO 13485 certification?
Having the ISO 13485:2003 certification indicates that the manufacturing facility maintains quality procedures and documentation identifying the controlling conditions used in the processes of medical device manufacturing. SEA-LECT Plastics uses the procedures to govern risk management and lot traceability for each step of every process used in manufacturing components and finished products. The components and devices we manufacture are classified in three classes under FDA regulation. Class 1, Class 2, or Class 3 is dictated by critical risk factors involved with the component or device. Each level requires different levels of regulation and compliance.
Should You Consider Plastic Injection Molding for Your Next Medical Product?
Plastics offer advantages compared to other materials that are commonly used with medical device manufacturing. Engineered resins when chosen for the correct application can offer strength, heat stability, low cost, and shapes that are complicated or nearly impossible to create easily in other materials. Determining if plastics will be your best choice can be aided by an expert mold maker that also offers resin selection, turn-key assembly options, and program management to see the complete development cycle through with success. If you need expert advice from a partner that can help with your next product idea, call us (425) 339-0288 or email us at firstname.lastname@example.org. We can offer you advice on the best technology to use, the best materials to meet your product demands, and how to navigate through each development stage. At SEA-LECT Plastics, we specialize in military product applications, outdoor adventure gear, musical instruments, and supporting the medical device manufacturing industry. Our goal is to make your project efficient and cost-effective to manufacture, assemble, and ship no matter how complicated your concept is.