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TENACITY ENGINEERING LLC

excellence in product development, project management, and design engineering

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Services

  • R&D/Product Development

    • Project management & design controls per 21 CFR 820, ISO 13485, ISO 14971 (risk management)

    • Concept development

    • Prototype design and development

      • CAD software: SolidWorks, Fusion 360, Onshape, Creo, Mimics/Materialise

    • Mechanical simulation, including nonlinear FEA structural analysis (contact, large deformation, nonlinear materials)

    • Product Design & Manufacturing drawings

      • DFX

        • Design for additive manufacturing

        • Design for manufacturing & assembly

        • Design for cleanability & sterilization

        • Design for regulatory compliance

        • Design for inspection

      • Tolerance analyses (1D, 2D, 3D, linear/nonlinear, worst case, statistical), GD&T per ASME Y14.5

    • Independent design reviewer (per FDA requirements)

  • Machine Design and Manufacturing Support

    • Gage design and development

    • Test fixture design and development

    • Manufacturing fixture design and development

  • With our partners

    • Quality system development and auditing

    • Regulatory Affairs

    • Intellectual Property development

Industries Served

  • Medical/Surgical/EMS

    • Navigated surgery

    • Surgical robotics

    • General surgery

    • Orthopedics (including spine, extremities, trauma and sports medicine)

    • Cardiac surgery

    • Urology

    • Blood processing

    • Catheters

    • Biopsy/Diagnostics

    • Women’s healthcare

    • Airway management

    • Patient handling

    • Rescue gear and tools

  • Aerospace

  • Outdoors and sports equipment

  • Consumer appliances

  • Office equipment

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