The Donatelle difference
For more than 50 years of medical device contract manufacturing, Donatelle has earned an unparalleled reputation for helping companies like yours develop innovative products and bring them to market quickly and cost effectively. We do this by adhering to the following principles:
Absolute quality standards
We’ve set the standard for excellence – our facility is FDA registered and inspected and has a pristine record of regulatory compliance.
Pure medical expertise
Our specialists focus exclusively on medical device design, development and manufacturing, helping you meet the industry’s most stringent regulatory requirement while keeping costs in check.
Relying on a single source from design to delivery helps optimize project communication, lead times and supply chain efficiencies.
High program value
We work with you through our Design for Manufacturing (DFM) process to identify significant savings opportunities from the start of your project. We help achieve savings through efficient program and tool management, consolidated resources and lean initiatives.
We manage our finances prudently. We also invest in learning and innovation to stay ahead of industry best practices, regulations and emerging technologies.
More about us
Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.