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
Mechanical Testing, Sterilization, Packaging, and Biocompatibility Evaluation
Engineering Analyses, including Finite Element Analyses
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.