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