About Us

Partner with us to deliver your medical device promise

For more than 45 years, we’ve helped the best, most recognized names in the industry enhance – and save – lives by helping to develop and deliver critical medical devices to market.

Founded as a tool design and fabrication business in 1967, Donatelle today is an FDA-registered, ISO-9001 and 13485 certified medical device manufacturer. We are a recognized leader in contract manufacturing for reliability, consistency and highest overall value, and manufactured thousands of products – in volumes ranging from a few hundred to millions of parts – in the course of our history.

We focus exclusively on medical device design, development and manufacturing, and specialize in intricate applications – high-risk, long-term implants and disposables – where precision, tolerances, validation and timelines are critical.

Our highly qualified team has extensive experience across a variety of markets, including Cardiac, Diagnostics, Drug Delivery, Neuromodulation, Ophthalmics, Orthopaedics, Surgical Technologies and Vascular.

Around the clock, we provide exactly the level of support our partners need, from a single manufacturing process to a complete solution requiring design through delivery.

Above all, we’re here to give our partners absolute confidence in the products they bring to market, at each stage in the process. We use proven, rigorous processes backed by our long history of expertise, investment in learning and best-in-class technology.

Your single source, end-to-end

  • Product Development
  • Prototyping
  • Injection Molding
  • Liquid Silicone Molding
  • Micromolding
  • Precision Machining
  • Secondary Operations
  • Assembly and Packaging
  • Sterilization Management
  • Process Validations
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Value of Partnering

In our more than 45 years in medical device contract manufacturing, Donatelle has earned a stellar …

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Living Our Values

At Donatelle, we believe that to be one of the best medical device companies today, we need to live …

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Quality & Certifications

When it comes to meeting exacting standards for your products, it’s not just our business …