Capabilities
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
- Review of documentation for regulatory submissions
Product Design and Mechanical 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