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Medical Device Consulting Services
Product Development
Whether you are developing a new product or modifying and existing one you can leverage our expertise to move your product forward
Manufacturing
Don’t let manufacturing lead-time’s delay your project. We work with a broad network of manufactures we'll find quickest lead time in industry
Quality Management
We have extensive expertise in Quality System design & implementation, let us help maintain, update & develop your ISO 13458 Quality Management System
Regulatory
Organization can benefit from our knowledge of FDA regulatory requirement by allowing us to assist in the authoring and compiling of 510(k) submission
Spinal Implants
FDA Audit Prep
510(k) Approval
Surgical Instruments
New/Novel Ideas
Process Validations
DFMEA/PFMEA
Optimize Fit & Function