Prototype Development Range:

  • 3-D printing via SLA, DMLS, & EBM and 3-D scanning

  • Fully machined/fabricated implants, instruments, and re-processing cases.

  • Coordination of consultation on designs with physicians on the IMSE Faculty

Design Verification:

  • Mechanical Testing, Sterilization, Packaging, and Biocompatibility Evaluation

  • Engineering Analyses, including Finite Element Analyses

Design Validation:

  • Onsite/Offsite Cadaver Labs & Dry Handling Simulations/Evaluations

  • Product Risk Management and Analysis per ISO 14971

  • Market Development, Product Management, and Product Launch Support:

  • Project Forecasting that accounts for P&L, ROI, SG&A, breakeven, …etc.

  • Vendor sourcing with Collaboration/Evaluation of First Article Inspection and Form, Fit, and Function Controls.

  • Quality control and inspection documentation, equipment, and training

  • Generation of rendered images and animation videos for on-label medical device promotion

  • Completion of Design History Files (DHFs) that comply with 21 CFR 820.30 and/or Technical Files (TFs) that comply with ISO 13485

  • US FDA Class II Device 510(k) Submissions & Responses

  • Product development documentation compliant with your preferred Quality Management System (QMS), or IMSE’s QMS.

  • Updating existing DHFs & Technical Files due to Design Changes.