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QAdvis AB
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QAdvis AB is a longtime trusted service provider for the medical device and in vitro diagnostic device industry. We offer a complete range of multidisciplinary services within quality, regulatory and clinical evidence. This includes European Authorized Representation services for non-EU manufacturers and UK Responsible Person services for non-UK based manufacturers from our British office QAdvis UK Ltd. Our team members are very experienced and active participants in several key international standardization committees and EU commission workgroups, writing standards and guidelines. We do this work to find the most cost effective approach to your regulatory challenges. Over the years, our team has successfully conducted a large number of expert assignments, thereby establishing partnerships and alliances with clients, industry, trade associations and an international network of expert consultants. In the quality field we build quality processes, audit processes and improve quality management systems compliant with ISO 13485 and QSR (Quality System Regulation) and other applicable regulatory requirements. We help companies to be both efficient and compliant at the same time. Processes must never be over-compliant. QAdvis' team members are active participants in several key international standardization committees and EU commission working groups, writing standards such as ISO 13485, IEC 62304, IEC 82304-1, IEC 62366-1, IEC 60601-1, ISO 14971 and EU MEDDEV guidelines. All this to support you in finding an efficient implementation of regulatory requirements.QAdvis AB is based in Sweden with two offices – Lund and Stockholm. We are about 25 senior and expert consultants supporting clients worldwide, with an emphasis on Scandinavian and European companies.