About Us Medical Markets Capabilities Case Studies Expert Insights Careers News Contact Us Medical devices and components for ophthalmics Home / Medical Markets / Ophthalmic devices We’ve helped ophthalmic product development teams like yours meet the industry’s most stringent regulatory requirements for Class I, Class II and Class III medical devices and components, including intraocular implants and surgical devices. Manufacturing intricate microparts consistently and cost-effectively requires special knowledge and utmost care. Our team of engineers, designers, machinists and toolmakers work together at our vertically integrated facility, which features controlled environments and ISO 7 (class 10,000) certified cleanrooms, as well as cleanroom production cells with integrated vision systems that operate at the ISO 5 (class 100) level. From design for manufacturability through delivery, your team can rely on us to: 45+ molding machines (5- to 300-ton capacity) to precisely produce molded components – including micro-, insert- and over-molded. 40+ Swiss CNC turning centers and two 5-axis bar-fed machining centers for precision machined components. Expertise and experience across all engineered and implantable-grade plastics (including polymers, silicones and PEEK), metals (including stainless steel, titanium and MP35N) and exotic materials. Specially designed systems and absolute quality standards to achieve extremely tight tolerances Plus, we’ve set the standard of excellence for quality systems – our facility is FDA registered and inspected with no Form 483 observations. We’ve also earned – and maintain – an impeccable track record for regulatory compliance, meeting deadlines and on-time delivery The best, most recognized names in the industry have relied on us for more than 50 years to deliver critical medical devices to market – and so can you! EXPERT INSIGHTS Conquer the challenges of micro-manufacturing Learn more about best practices for precisely and reliably producing microparts in “How to Conquer the Challenges of Micro-Manufacturing”. GET THE WHITEPAPER Rely on our micromolding expertise for your Class I, Class II and Class III Ophthalmic medical product needs, including: Intraocular implants Surgical devices And more! 501 County Road E2 Extension New Brighton, MN 55112 Phone: +1-651-633-4200 Fax: +1-651-633-5486 ©2021 Donatelle. All rights reserved. Donatelle and the Donatelle logo are registered trademarks of Donatelle Plastics Incorporated. | Privacy Policy