Worth its weight.
Total value.
Make a rock-solid investment in the development of your priceless Class II and Class III implantables that rely on bioresorbable materials.
Count on the next-gen technology and treasured know-how of Donatelle!
We offer unparalleled experience and expertise meeting the highly rigorous preparation, processing and handling required to accommodate their special characteristics and temperature-control needs.
We also have the special knowledge needed to help you meet their stringent regulatory requirements and approval processes.
Get in on it!
Donna Materna
(818) 785-5112
donnam@pentagonco.com
Learn how a process integration model is emerging to overcome the challenges of micro-manufacturing and meet the unique needs of manufacturing micro size medical device parts.
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
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