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

Compliance & timeline risks

Check out the Donatelle guide to learn more about “How to Avoid Compliance & Timeline Risks”

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