The United States is the world´s largest dynamic medical device market. Espacially for startups and SMEs it is a key step for market entry.
The medical device approval under the Food and Drug Administration (FDA) is based on a risk-based classification system and offers execptional opportunities for innovation and growth with a transparent approval system, predictable cost, and fast procedures.
WQS provides, with offices in Germany, Florida, and California, both European and U.S. market expertise ensuring seamless communication and compliance throughout the process of successful market launch and beyond.
Our services, your advantge:
• Regulatory consulting & optimal FDA classification for your device
• FDA approval procedures through 510(k), PMA, or Do Novo pathways
• Acting as your US representative
• Quality management & GMP compliance to ensure full regulatory adherence
• Market entry & strategic consulting from initial to successful launch and beyond
Consulting. Registration. Market success.
WQS provides reliable support throughout the entire approval process and beyond. Get off to a successful start on the US market with FDA 510(k) & Co. with us.
We are here to support you in successfully establishing your innovations on the US market – feel free to contact us directly.
- WQS Management Consultants Inc.
