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Services
Research, Design & Development Analysis & Testing
 | Concept Studies & Development |
| Solid Modeling |
| Design Reviews |
| Design Verification & Validation |
| Clinical / Surgical Input* |
| Project Feasibility |
| Competitive Product Analysis |
| Intellectual Property Review* |
| Project Plans |
| Product Specification/Design Input |
| Material Selection |
| Geometric Dimensioning and Tolerancing (GDT) |
| Tolerance Analysis |
| Design for Assembly |
| Design for Manufacture |
| Detailed Drawings & BOM |
| Industrial Design & Human Factors* |
| Packaging & Labeling Design* |
| Technical Due Diligence |
Fabrication
| Prototyping* |
| Small Scale Manufacturing* |
Analysis & Testing
| Finite Element Analysis |
| Tissue Testing* (Animal & Cadaver) |
| Static and Fatigue Testing* |
| Bench Top Testing |
| Test Equipment Design & Fabrication |
| Risk Analysis/Management |
| Failure Mode & Effects Analysis |
| Bio-Compatibility Testing* |
| Design for Sterilization * |
| Stability Testing * |
| Packaging/Transportation Testing* |
Quality & Regulatory
| Design History File |
| Design Dossiers for CE Marking* |
| Quality Plans |
| Device Master Record |
| Regulatory Pathway Support* |
| Regulatory Submissions Support* |
| Quality Systems Consulting* |
Other Services
| Gage Design and Fabrication |
| 3D Animations |
* This service may be subcontracted through a qualified outside source.
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