Company profile

Medical Device Consult (MDC) is a Danish based consulting company founded in 1995 by Vivi Thulstrup. Today, MDC is managed by Henrik Kvistgaard.

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

MDC can assist your company through interpretation of the regulatory requirements relevant for the product in question and a range of services to facilitate the CE marking process in Europe or the 510(k) & PMA process with US FDA.

Developing, implementing and maintaining a Quality Management System, specifically encompassing the processes relevant for your company, is among the tasks where MDC can offer you practical assistance.

The Quality Management System is developed in an interactive process with your company to accommodate your needs and, to the extent it is relevant, incorporate regulatory requirements.

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