WQS Management Consultants is proud to announce the launch of our U.S. entity, WQS INC, based in Florida. This new business expansion allows us to better serve U.S. Market-based life science companies aiming to bring their medical devices and combination products to the European market.
While WQS was originally founded in 1993 in Germany, the addition of WQS INC marks a strategic step in our global growth — and strengthens our commitment to helping clients navigate complex EU and FDA regulatory requirements with confidence.
With locations in Hamm, Germany and Florida, USA, we offer specialized consulting in:
✔ CE Certification (MDR)
✔ ISO 13485 QMS Development
✔ Clinical Evaluation
✔ Risk Management
✔ Technical Documentation
✔ Support for high-risk, active, and substance-based devices
✔ Market entry strategy for US companies targeting the EU
Our mission is to simplify regulatory compliance across borders — from concept to certification.
