Medical devices and components for surgical technologies

medical device product development process
Over the past 50-plus years, Donatelle has reliably and cost-effectively manufactured millions of surgical components for Class I, Class II and Class III medical devices, including for ear, nose and throat (ENT), laparoscopic, women’s health and urology products – and more.

For surgical technologies, many of our customers take advantage of our high-volume manufacturing capabilities. For volumes of hundreds of thousands to millions of units, these leverage our:

  • Low-cost, manufacturing model comprised of specialized design for manufacturability (DFM) services, “lights out” automation processes and robust lot control.
  • Integrated automation and inspection capabilities to minimize manual interaction and maximize consistency.
  • Continuous operations to meet supply chain and forecast needs.
For both high- and low-volume products, our capabilities range from concept through DFM, prototyping, validation, manufacturing, assembly, barcoding, package labeling, sterilization management and delivery – all implemented with our absolute commitment to quality.

Plus, we have earned – and maintain – an impeccable track record for regulatory compliance, meeting deadlines and on-time delivery.

Expert insights

7 Critical Factors for Predictable Quality in Medical Device Manufacturing

We offer deep experience as your single contract manufacturing source for producing Class I, Class II and Class III surgical technologies, including:

  • Biopsy devices
  • Bioresorbable fixation components
  • Cosmetic Surgery
  • Cryoablation
  • Dissection devices
  • Ear, Nose & Throat (ENT) devices
  • Endoscopic suturing devices
  • Feeding Tubes
  • Laparoscopic and minimally invasive devices
  • RF therapy devices
  • Surgical staplers
  • Women’s health and urology products
  • And more!

Our suite of integrated contract manufacturing services, enhanced by our SmartStack® and NeuroStack® technologies, provides a competitive advantage with customizable linear contact systems. Plus, our facility features controlled environments, ISO 7 (class 10,000) cleanrooms and cleanroom production cells with integrated vision systems capable of operating at ISO 5 (class 100) level. *Moldflow® is a registered trademark of Autodesk® Inc.

501 County Road E2 Extension
New Brighton, MN 55112
Phone: +1-651-633-4200
Fax: +1-651-633-5486