- 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
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
Quickly, inexpensively test your concepts with US & Offshore talent