Representatives For

Texas, Oklahoma, Arkansas, Louisiana

For more than 50 years, we’ve helped the best, most recognized names in the industry enhance – and save – lives by providing injection molded and precision machined components that help our customers deliver cutting edge products to the medical industry.

Donatelle today is an FDA-registered, ISO-9001 and 13485 certified medical device contract manufacturer with end-to-end capabilities that include:

injection molding

micro molding

liquid silicone molding

precision machining

metal injection molding

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.

We focus 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.

Cardiac • Diagnotics • Drug Delivery • Neuromodulation • Ophthalmics • Orthopaedics • Surgical Technologies • Vascular

Contract Manufacturing

Exclusive focus on medical device design, development and manufacturing for intricate applications where precision tolerances, validation and timelines are critical.

Vertically integrated services that span:

  • medical device design
  • development, prototyping, validation
  • manufacturing
  • assembly
  • barcoding
  • packaging
  • labeling
  • sterilization management
  • delivery

ISO 7 (class 10,000) certified clean rooms

ISO5 (class 100) cleanroom production cells with integration vision systems

FDA registered and inspected

ISO-90001 and ISO-13485

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Precision Machining

Tenured machinists, state-of-the-art technology and a continuous investment in developing our team of specialists and equipment.

Specific precision machining capabilities include:

  • Multi-axis CNC machining, including Swiss turning and vertical milling
  • Wire EDM
  • Fininshing operations
  • Precision cleaning

2.0 Ppk on all projects to ensure we’re meeting your specifications and industry requirements.


  • Stainless steel
  • Titanium
  • MP35N
  • Nitinol
  • PEEK
  • Many other specialty metals, plastics and alloys

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Injection Molding and Micromolding

Whatever your material we’ve got you covered.  We will be happy to work closely with your design team to select the best polymers – thermoplastics and elastomeric – and metals – stainless steel and MP35N – to bring manufacturability, accuracy and consistency to your molded component.

Our in-house facility features more than 45 molding machines ranging from 5- to 300-ton capacity, to precisely produce micro, insert and over-molded components that weight from less than 1 mg to 0.5 kg.

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