Count on the single source with 50+ years of experience reliably and cost-effectively manufacturing millions of surgical components for the best, most recognized names in the industry.

EVERY COMPONENT COUNTS.

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To talk about how Donatelle can help you cost-effectively deliver your high-volume products cost-effectively with absolute quality, contact us.

Contact Us at Fusion Sale Group

Your single source for medtech - that’s in spec, on time and on budget

Products developed and delivered on time, virtually every time.

  • An impeccable record of meeting product development deadlines
  • More than 99% on-time delivery rate

Capabilities

End-to-end collaboration – from concept to design, through delivery:

  • Product Development
  • Prototyping
  • Injection Molding
  • Liquid Silicone Molding
  • Micromolding
  • Precision Machining
  • Secondary Operations
  • Assembly & Packaging
  • Process Validation

Get ultimate functionality, repeatability and cost-effectiveness

Quality

Absolute quality backed by rigorous processes that helps reduce total costs.

  • Compliant quality management systems that support FDA audits
  • Process control plans based on validation results and customer requirements
  • Quality Assurance processes utilize ISO 9001:2015 and ISO 13485:2016 certified systems

Expertise

Pure medical expertise in virtually all medical markets, especially for intricate applications – like high-risk, long-term implants and disposables – where precision, tolerances, validation and timelines are critical:

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