Our medical device manufacturing company

For more than 50 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 contract manufacturing company. Our company is a recognized leader for reliability, consistency and highest overall value, and has manufactured thousands of products – in low and high volumes ranging from a few hundred to millions of parts – in the course of our history.

Our company focuses exclusively on medical device design, development and manufacturing, and specializes 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, our medical device manufacturing company provides exactly the level of support our partners need, from a single 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 and Rapid Tooling
  • Injection Molding
  • Liquid Silicone Injection Molding
  • Micromolding
  • Precision Medical Machining
  • Secondary Operations
  • Assembly and Packaging
  • Sterilization Management
  • Process Validation

Value of partnering

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

Living our values

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

medical device manufacturing

Quality & Certifications

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