Life Sciences companies, including medical device and pharmaceutical companies, strive to improve patient outcomes by driving innovation, personalization and enhancing product quality. The Food & Drug Administration (FDA) encourages Life Sciences companies to use additive manufacturing to achieve these goals, yet there are many complex regulations for them to manage.
RIZE’s patented additive manufacturing process, with significant innovations on materials, allows Life Sciences companies to meet or exceed the ‘Document’, ‘Describe’ and ‘Identify’ requirements outlined in the regulatory guidelines, as well as FDA 21 CFR 820.30 design control requirements. Companies like CONMED and Merck use RIZE 3D printers to safely and easily produce parts with best-in-class Z-strength to improve medical device design, including functional parts and molds for elastomeric parts to perform real-world appliance testing. RIZE 3D printers can even print secure information on a functional part, such as a QR code, to produce the industry’s first Digitally Augmented Parts that connect the physical part to its digital record, providing traceability, compliance and authenticity.
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