Business Profile
“When I don’t get involved until a late stage, we may have to find temporary solutions that will require more work later.” His point is that quality can’t wait. In his opinion it is time saving and much more efficient to ensure that QMS is in place at an early stage of the production process.
Staying updated in the niche Henrik Kvistgaard has more than 18 years of experience from the medtech industry. He has successfully been in charge of MDC for four years, since he took over the business from the founder, Vivi Thulstrup. He is a mechanical engineer by trade and staying up-todate is part of his job. Henrik Kvistgaard continuously educates himself within his area of expertise, keeps track of news from regulatory authorities and certification bodies on an international basis and attends courses and conferences. “Working in a niche area allows me to dig deeper and provides a fundamental insight into the challenges of my customers,” Henrik Kvistgaard concludes.
About Medical Device Consult (MDC) MDC is s a Danish based and globally operating consulting company that has specialized in assisting Medical Device and In-Vitro Diagnostic companies in meeting US & European regulatory and Quality System requirements MDC can assist 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 MDC was founded in 1995 For more information: medecon.dk
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