Donatelle… A Trusted Partner of Medical Device OEMs
Founded as a privately owned tool design and fabrication business in 1967, Donatelle evolved into an FDA compliant, ISO-9001 and ISO-13485 certified, full-service medical device manufacturer in Minnesota that ships product worldwide. Donatelle excels at providing highly customized medical devices and components to companies large and small. We focus 100% on the medical industry, with medical device manufacturing expertise in areas such as cardiac rhythm management, neuromodulation, cardiovascular surgery, diabetes, and spine.
By leveraging the power of collaboration, we will help you achieve shorter time to market, more robust product design, and highly effective product launches. We offer a full range of capabilities spanning needs from product conception through commercialization.
With medical breakthroughs occurring faster than ever, absolute confidence in the products you bring to market is a must. Whether it is adherence to product specifications or regulatory requirements, Donatelle understands this perfectly. We utilize our expertise to deliver products that prove themselves through accuracy, repeatability, and reliability. Donatelle relies on state-of-the-art technology and innovative manufacturing techniques to provide a single-source manufacturing solution that meets the medical device industry’s most demanding performance requirements. The components and assemblies Donatelle manufactures will ensure you deliver the life changing devices your patients need, when they need them, every time.
Contract Manufacturing Competencies to Precisely Fit Your Needs
Thermoplastic and Elastomeric Injection Molding
Liquid Silicone Injection Molding
White Room and Class 10,000 Cleanrooms
Welding (plastic and metal)
Full Device Assemblies
Lowest Total Program Cost
Experienced sourcing specialists know the cost of a program goes beyond the quote. When it comes to total program cost, medical device companies rank Donatelle among the very best. Beginning with early program involvement, we are often able to provide significant savings through our design for manufacturing (DFM) efforts. Other significant program savings result from our efficient program management, consolidated resources, lean initiatives, and tool management.
As an FDA registered and ISO- 13485 and ISO-9001 certified facility, Donatelle boasts a superb quality record. With approximately half of our business involving implantable devices, many patients’ lives depend on us. Every Donatelle employee has a vested interest in meeting your quality standards.
Delivery You Can Count On
Whether it relates to adherence to product development schedules or delivery of finished goods, you can count on Donatelle. We lead the industry in delivering on time and on budget. Using real-time planning and management tools, we proactively capture and report performance metrics so you know where your device stands at any given time. We are proud to share that our on-time production delivery record has averaged over 99% for the past five consecutive years.