Challenge

New product design without established manufacturing and testing processes

Product design was fluid with many design changes – requiring a very flexible medical CM

Steep production ramp made supply chain management challenging

Outcomes

Evolve successfully ramped from zero to 400 units per month within 4 years

Shipped 100% on time for 16 consecutive quarters and 6 sigma quality levels

Processed many engineering changes and deviations while adhering to all regulatory requirements

Led customer on regulatory requirements

Shipped equipment to medical facilities and hospitals world wide.

 

Value Proposition

For fast paced medical device manufacturing Evolve is the only local choice

Evolve’s senior management team are all experienced medical device professionals

With deep knowledge of FDA requirements, and will get your product to market quickly and safely

Silicon Valley location allows for instant communication with the fastest product launch