News & Events


 

FDA Announces 2011 User Fees for Medical Devices - Aug. 1, 2010

 

Alquest Seminar: Sept. 16- 17, Minneapolis, MN:

Traditional and Novel Sterilization Methods of Medical Devices

 

 

Alquest CEO quoted in June 24 Businessweek-Bloomberg story on expanding FDA requirements for device companies

 

 

 



Meet The Team

 

Alquest is a CRO specialized in medical devices, in vitro diagnostics (IVDs), biologics and combination products.


Alquest is a CRO (clinical research organization and regulatory consultancy) specialized in medical devices, in vitro diagnostics (IVDs), biologics and combination products.


We are the preferred provider of regulatory, clinical and compliance services to several of the world’s largest device manufacturers, as well as leading venture-backed startups.


Services on Demand
Turn us on. Turn us off. Alquest’s involvement is determined by your need. Depending on your company’s size, development stage and staffing model, Alquest performs different roles for different clients. We not only advise, we do the detailed work of

  • Regulatory strategy & submissions
  • Clinical design and clinical trial conduct
  • Quality Systems and compliance

Since 1993 Alquest has served over 400 medical device firms. Our clientele is national and international, including current medical device clients from Germany, UK, Austria, Switzerland, Denmark, Australia, Japan and Korea.

 

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