Donatelle

At Donatelle, we make products that enhance – and save – lives. We are a leading contract manufacturer that helps bring critical medical devices and components to market – from design through delivery. That’s all we do. And we do it with the utmost precision, consistency and rigor, because for our customers – and theirs – quality is essential. Reliability is a must. And delivering on what’s promised is vital.

For more than 50 years, we’ve helped the best, most recognized names in the industry meet the most stringent regulatory requirements, especially for intricate applications, including high-risk, long-term implants and disposables. And we’ve earned – and maintain – an impeccable track record of meeting product development deadlines and more than 99% on-time delivery rate.

We are FDA registered as a contract manufacturer focused exclusively on medical device design, development and manufacturing. Our state-of-the-art manufacturing facility features controlled environments and ISO 7 (class 10,000) certified cleanrooms, as well as cleanroom production cells with integrated vision systems that can operate at ISO 5 (class 100) level.

We pride ourselves on consistently providing exactly the level of support our customers need – from a single manufacturing process to a complete solution. And our highly qualified, experienced team can partner with our customers through each stage of the development and manufacturing process – end to end.

Our long-standing history allows us to offer our customers expertise in a number of different medical markets, including cardiac, diagnostics, drug delivery, neuromodulation, ophthalmics, orthopaedics, surgical technologies and vascular. To learn more about our end-to-end capabilities and the markets we serve, visit our website DonatelleMedical.com.

Company’s Keywords:

contract manufacturing, product design & development, prototyping, injection molding, liquid silicone molding, micromolding, precision machining, secondary operations, assembly & packaging, sterilization management, process validation