In two shakes. Launch in stride!
Navigating the medical market and its governing regulations requires special knowledge and utmost care. It also requires specially designed, vertically integrated systems and absolute quality.
Confidently meet the industry’s most stringent regulatory requirements, while keeping costs in check, so your products will launch in stride!
Rely on Donatelle to shepherd your medical devices and components seamlessly.
Your single source for medtech - that’s in spec, on time and on budget
Join the best, most recognized names in the industry. For more than 50 years, Donatelle has served as their go-to contract manufacturing partner for complex and intricate medical devices and components.
For virtually all medical markets and low-to-high volume needs, rely on Donatelle’s:
End-to-end capabilities • Absolute quality • Pure medical expertise
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 and ISO 13485 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