Business Sense

Compliance

Since inception, QDS has completed hundreds of clinical trials successfully, and has had the opportunity to provide service for multiple commercially-available products.  We are very proud of our quality record in that we have never failed a Quality Control Audit, and that both Sponsor and Site FDA audits have been without issue or 483s. 

FDA Audit History

  • 2008 – 510K Submission; CE-mark and FDA approval
    • No 483s
  • 2006 – FDA Audit of QDS
    • No 483s
  • 2005 – SNDA Submission global CNS
    • QDS – CDM pivotal trial with QDS-EDC
      • No 483s
  • 2004 – SNDA Submission
    • QDS – CDM pivotal trial with QDS-EDC
    • Site Audits
      • No 483s

Approximately 85% of our business is from repeat clients.  We believe this speaks volumes with regard to quality, value, and our high commitment to customer satisfaction.