Product Design & Development
Manufacturing
Testing
FDA Submission
Product Design and Development
We start with your ideas and use thorough engineering practices to turn those ideas into high quality, manufacturable, profitable products. We are very detail oriented and take pride in our design working hard to design quality into the products, in addition we always keep manufacturing in mind helping to manage cost.
Software
We have licenses for the latest versions of the best engineering tools for medical devices. The majority of products using SolidWorks© CAD software, but others are available upon request if necessary.
We also own software licenses for the development of complex and trabecular lattice geometries for Additive Manufacturing (3D Prining) and osseointegration.
Finite Element Analysis (FEA)
Let us help you pass mechanical testing the first time with our extensive experience in computational modeling.
Manufacturing
We have manufacturing partners all over the country with all capabilities necessary to produce the finest quality products. Our partners are ISO 13485 certified and the majority are registered with the FDA.
- Additive Manufacturing (3D Printing)
- Swiss Turning
- Multi-Axis milling
- EDM
- Anodizing
- Packaging
- etc.
Mechanical Testing
We have experience in many aspects of mechanical testing for medical devices and can help guide you in the right direction to get your product to market quickly.
Quality and Regulatory
We have successfully helped achieve 510k approval on many devices, and we can help guide you through the process for your device.