Donatelle is a leading custom and contract manufacturer serving the medical industry, with special expertise in implantable devices. We offer world-class experience in the areas of molding, machining, and device assembly. Our Company is focused on assisting customers with designing, developing, and manufacturing high-quality product.
MAJOR MARKETS Donatelle serves many facets of the medical industry, including the implantable component market. Some of the markets we serve include cardiac, diagnostics, drug delivery, neuromodulation, ophthalmics, orthopaedics, surgical technologies and vascular.
SERVICES OFFERED As a vertically integrated contract manufacturer, Donatelle offers progressive solutions to ensure successful product realization for medical component manufacturing through device assembly, packaging, and sterilization management. We are ISO-9001:2015 and 13485:2016 certified, FDA compliant, and our manufacturing processes are validated according to Quality System Regulation 21 CFR Part 820.
At Donatelle, we believe early design involvement ensures optimum component and product integrity. We partner with our customers and provide them with a project team approach, and we employ the industry’s best engineers and technical experts to assist with product design and development. These industry experts work diligently with our customers every step of the way. If needs include prototyping or rapid tooling, Donatelle can provide near net shape samples with typical tolerances of ±0.005” within a turnaround time of as little as a week, dependent on design complexity.
Donatelle offers expert processing capabilities for the entire range of engineered resins. Our production floor operates 24 hours a day, 5 days a week and houses over 40 molding machines that range from 5- to 300-ton capacity. Molding is performed in controlled environments and cleanrooms, and is monitored by our ERP System which has a direct interface with our primary processing equipment for optimum throughput.
We also offer precision machined component fabrication. Donatelle specializes in close tolerance components and is experienced in working with a wide variety of materials. Processes available in-house at Donatelle consist of Swiss CNC including multi-axis Swiss machining centers, wire EDM work cells that are robotically controlled allowing us to better serve you with a lights out automation process, vertical machining with full 5-axis simultaneous machining, and micro machining with CNC milling, turning, and EDM.
If your device requires validation, Donatelle is the supplier you can trust! We understand what is required by the FDA. Our technical experts are experienced in process validation methodologies, validation sampling techniques, Geometric Dimensioning and Tolerancing (GD&T), scientific process development, and sterilization management.
For more than 50 years, Donatelle has delivered by setting the standard of excellence in medical device and component manufacturing. We have earned—and maintainan impeccable track record for regulatory compliance, meeting deadlines, and on-time delivery. Learn more about how we can help bring your medical devices to market—with confidence.
The market need was strong, the timing tight and the challenge steep: A large OEM set out to address the demand for real-time glucose management for critical care patients. Timing for the product launch was critical—and tight. But…
A fast-growing medical device company aiming to be a global leader in minimally invasive spinal therapies asked Donatelle for design assistance in improving an existing device. The product, a bone cement mix and transfer system, had a hi…
In today’s medical device marketplace, timing is everything. So when a company needed to develop and manufacture a surgical device that would improve ease of use over existing models and eliminate failure modes—and needed deliv…
Developing a new medical device, especially a long-term implant, is never easy. But bringing an entire metal implant line of over a hundred parts to market raises the difficulty factor to a whole new level. That was the challenge a growi…
A medical device OEM came to Donatelle with a problem. One of their products, a device used for rapid sternal access in the administration of medications, was occasionally failing during training—a serious issue in the emergency si…