Medical devices and components for surgical technologies
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!
