About: Alquest Experience
Alquest’s experience spans all manner of technologies, therapeutic areas and assignments.
General Firm Experience
- 17 years in the medical device business
- More than 1,100 medical devices supported
- More than 400 medical device manufacturers supported
- Supported hundreds of 510(k) clearances
- Supported dozens of PMA approvals
Project-Related
- 25+ Quality systems implementations (new)
- 25+ Clinical evaluation reports
- 40+ submissions for FDA requests for additional information
- 50+ Gap analyses
- 80+ Literature/bibliography searches and summaries
- 100+ Technical files
- 100+ Risk assessments/summaries
- 100+ Summaries of clinical and pre-clinical data