SERVICES THAT EXCEL
Total Client Satisfaction
Delivering a final product with
service that exceeds customer expectations
We offer a wide range of
Product Design and Engineering services
focused on helping companies rapidly develop and commercialize their Medical Device technology, turning innovative ideas into market ready products
Our Services
- Fast-Track Product Development
- Research & Development
- Injection Molded Product Design
- High Volume Injection Molded Disposables
- Industrial Design & Product Concepts
- Proof of Concept Functional Prototypes
- Process & Manufacturing Equipment
- Manufacturing Assembly Tooling & Fixture Design
- Verification and Validation Testing
- Packaging Design
- Design & Documentation
Specialized Expertise
- Clinical Feasibility Studies (Animal & OUS)
- Grant and Capital Fundraising
- Contract Manufacturing Management
- Supply Chain Management (US & China)
- Intellectual Property — Creation & Defense
- ISO 13485 Quality Management System
- Quality Assurance
- FDA Submissions — IDE, 510k, De Novo, PMA
- EU MDR / CE Mark Approval
- Market Research & Focus Group Studies
Creating products that can be easily manufactured starts at the beginning of the design process. Our manufacturing expertise is a key asset and the foundation of our design process — ensuring your ideas are successfully executed into commercially manufacturable products, right from the start.
+
Years in Medical Device Design
+
Medical Device Clients
+
Products Developed