Take advantage of pure expertise
For both high- and low-volume products, our capabilities range from concept through DFM, prototyping, manufacturing, assembly, barcoding, package labeling, validation, sterilization management and delivery – all implemented with our absolute commitment to quality.
Learn more about why the industry’s leading companies confidently rely on us to successfully bring their Class I, Class II and Class III medical devices and components to market – in spec, on time and on budget.
As specialists focused purely on medical device design, development and manufacturing, we offer a critical understanding of product needs and regulatory requirements. Our market expertise includes:
"I've used headers from Donatelle for over 12 years and have always been pleased with the quality of your work."
– VP of Product Development, Cardiac Rhythm Management Device Company
"Donatelle offers very high quality, is dependable, and is a great long-term partner."
– Buyer-Planner, Cardiac Surgery Device Company
"I have seen Donatelle turn things upside down to make things right for us."
– Project Manager, Spine Device Company
"We like [that Donatelle] specializes in medical, because there are a lot of hoops to jump through."
– Engineering Manager, Dental Implant Company
‘’With Donatelle, Quality always comes first.’’
-VP of Engineering, Implantable Cardiac Device Company
"There are other suppliers who could not do it, and would have less motivation to provide the...quality needed for medical devices. Donatelle is certainly aware of what it takes to be a medical device supplier."
– Strategic Sourcing Manager, Neurostimulation Device Company
“We have been working with Donatelle for several years on new product projects and know they have the resources and expertise to hit deadlines. Donatelle is the Gold Standard that I wish my other suppliers could achieve."
– R&D Engineering Manager, Cardiovascular Company
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.