Most of our work is geared towards medical devices.  For this reason, our design, engineering, and documentation efforts  are consistent with best practices for document control in an FDA-regulated environment.

 

Project Management

  • Project Schedule and Task Management
  • Product Data Management (PDM) – setup and use
  • Product Lifecycle Management (PLM) - setup and use
  • Managing the Bill of Materials (BOM), including costs
  • Advice on Regulatory Strategy for FDA and CE submissions
  • Risk Analysis and FMEA
  • Review of documentation for regulatory submissions

 

Mechanical Design and Engineering

  • Industrial Design
  • User Interface Design
  • Graphic Design of Labels and Manuals
  • Product Illustrations and Renderings
  • Cosmetic Prototypes and Demo Models
  • Material and Process Selection
  • Design of Plastic and Sheet Metal Parts
  • Design of Optical Assemblies and Mechanisms
  • Functional Prototyping
  • Electronics Integration and PCB Layout
  • Cable Harness Design
  • Ingress Protection to IPX Standards
  • Production-Ready Documentation
  • Design for Assembly

 

Transition to Manufacturing

  • Vendor Research, Visits, and Selection
  • Tooling Drawing Review
  • Assembly Instructions
  • Fixture Design and Documentation