About Donatelle™ Medical Manufacturing

We accomplish our vision and mission through leadership committed to excellence through continuous improvement. All Donatelle efforts are based on the principles of respect, integrity, teamwork, contribution, and prosperity.

We create possibilities to improve the quality of life for humankind, one person at a time.

For more than 40 years, medical device companies have counted on Donatelle to be their trusted medical manufacturing partner. By engaging Donatelle, a manufacturer gains security and peace of mind that can only be realized through working with a company who truly speaks your language and caters to your unique and individual needs.

Founded as a privately owned tool design and fabrication business in 1967, Donatelle has evolved into an FDA compliant, ISO-9001:2000 and -13485:2003 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 are unique in that we focus 100% on the medical industry, with medical device manufacturing expertise in such areas as cardiac rhythm management, neuromodulation, cardiovascular surgery, diabetes, and spine.

By leveraging the power of collaboration, we help you achieve shorter time to market, more robust product design, and highly-effective product launches. We offer you a full range of capabilities, spanning your needs from product conception through commercialization.

With medical breakthroughs occurring faster than ever, you need absolute confidence in products you bring to market. 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.

Contract manufacturing competencies to precisely fit your needs.
  • White Room, Class 10,000 and Class 100,000 Cleanrooms
  • Welding (plastic and metal)
  • Bonding
  • Decorating
  • Assembly
  • Packaging
  • Sterilization management
  • Barcoding
  • Validations

Value of Partnering with Donatelle™

Living Our Values

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