Ways We Serve

Design Services

CAD modeling

CAD assemblies

Manufacturing + inspection drawings

Tolerance analysis

Mechanical testing

Prototype design and manufacture

Design for manufacturing

Fixture design

Gage design

Medical Device Development

Program + Project management

Project design reviews

Phase/stage gate reviews

Design history file

Surgeon design meetings

Cadaveric lab meetings

Risk analysis

Design verification and validation

Cleaning/packaging/sterilization validation

Operating Room support 

Limited + Full Commercial launch

Sustaining Design Engineering

Product line extensions

Medical Device QA/RA

Quality management system build and maintenance

Inspection plans and reports

Regulatory filing support

Post-market surveillance

Root cause analysis

Audit experience with GMED, BSI, FDA

IQ/OQ/PQ

What we do

What we don't do