Donatelle is focused exclusively on medical device design, development and manufacturing, especially for intricate applications – like high-risk, long-term implants and disposables – where precision, tolerances, validation and timelines are critical. For over 50 years, the best, most recognized names in the medical industry have relied on Donatelle.
Donatelle employs a team of over 40 highly specialized engineers, designers, machinists and toolmakers. Our staff is available to supplement your team, and they come with specialty certifications, including: IOPP Packaging, Process Validation, Medical Device Compliance, and Quality System Regulation Compliance.
Our vertically integrated capabilities provide exactly the level of support you need, from a single manufacturing process to a complete solution. We’ll save you time while reducing risk across each manufacturing phase. Plus, we’ve earned – and maintain – an impeccable track record of meeting product development deadlines and more than 99% on-time delivery rate.
Donatelle provides the highest achievable quality of products and services. We accomplish this through rigorous processes, continual improvement and maintaining effectiveness at all levels.
We make your medical device promise a reality.
Donatelle provides component and medical device manufacturing worldwide. We operate under ISO-9001:2015 and ISO- 13485:2016 certified systems and are FDA compliant. Capabilities include: complete engineering services, rapid prototyping, in-house tooling design and fabrication, processing capabilities for the entire range of engineered resins, micromolding, insert molding, over-molding, white room and clean room molding and assembly, liquid silicone injection molding, as well as precision machining for metal and plastic components.
501 County Road E2 Extension
New Brighton, MN 55112
Phone: (651) 633-4200