• Turnkey EU MDR services
  • From gap assessment to finished documentation ready to submit to your notified body
  • Experienced; two successful Design History File projects for Fortune 50 medical device companies
  • Innovative risk management documentation to accelerate the risk management file

...With a Proven Track Record

MEDICAL DEVICE DESIGN AND FDA SUBMISSION...

  • New product from concept to launch in 10 months with first year sales over $10MM.  
  • FDA approval of several medical devices using the Global Device Solutions proprietary quality system
  •  We have developed our own products.  Let us share examples of our documentation
  • Minnesota based engineers who also manage offshore projects

...With a Proven track Record

Our Mission

Provide “State of the Art” new product development and Legacy DHF Remediation services at world class hourly rates

Let us show you examples of projects GDS has completed for clients; either locally or using off shore talent.

New Product Development

Over 15 years experience with proven results

  • FDA Documentation with Bridge Tooling
  • Concept to Launch in 10 months
  • Launch with 16 cavity molds
  • First year sales >$10MM

Offshore Engineering

Quickly, inexpensively test your concepts with US & Offshore talent

  • US team created working 5 prototype concepts with client marketing
  • Ergonomic design (balloon pump built into handle)
  • After down select, Asian team designed 14 injection molded parts
  • Devices with prototype molded parts tested with >50 surgeons
  • Client quickly learned product was not feasible