Medical Device Consult ApS is a privately Danish owned consulting company founded in 1995 by Vivi Thulstrup. Since 2007, Medical Device Consult ApS has been owned and driven by Henrik Kvistgaard.

Medical Device Consult ApS has specialised in assisting Medical Device and In-Vitro Diagnostic companies in meeting the US & European regulatory and Quality Management System requirements.

Over the years, Medical Device Consult ApS has assisted more than 200 companies in obtaining CE-mark for their medical device or FDA clearance to market in the US.

Medical Device Consult ApS can assist your company through interpretation of the regulatory requirements relevant for your medical device and offers a wide range of services to facilitate the regulatory approval required for your medical device or your IVD.

 

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