Product Design and Development

MC3 has the tools and experience to transfer medical device technologies from the concept stage to commercial product. Our phased development approach is flexible and allows development to follow a process appropriate for the level of complexity and maturity of the device concept. This process has proven effective in managing financial risk and product risk while producing design output for FDA and EU regulatory submittals and easy transfer to production facilities.

 

  • 3D mechanical design (SolidWorks®)
  • Computational fluid mechanics/finite element analysis (ADINA)
  • Rapid and subtractive prototyping
  • Polymer fabrication (casting, dip molding, injection mold design)
  • Quality system
    • ISO 13485 based Quality System
    • Design Control per FDA 21 CFR Part 820
    • Risk Management per ISO 14971