qtec EuRep GmbH

European Authorized Representative We are a strategic partner for non-EU manufacturers of medical devices, who want to start or continue selling their products in the EU, one of the largest economies in the world. ★★ Your need ★★ In order to sell products, you as a manufacturer have comply with the requirements as laid out in the ‘Medical device Regulation' (EU) 2017/745 or the ‘In-Vitro Diagnostics Regulation' (EU) 2017/746. One of thes requirements is to designate an authorised representative in order to access the European market. We are an ‘Authorized Representative' as required per article 11 in both regulation (EU) 2017/745 and (EU) 2017/746. ★★ What drives us ★★ The well-being of the patient is our top priority. It fulfills us that with the help of our work, your products will be made available for patients safely, effectively and in time. Even if we do not develop, manufacture or sell medical devices ourselves, we are experts in the field of ‘medical devices' as we constantly gain distinctive knowledge while we continuously support medical device manufacturers all over the world without being your competitor. Our vision "if you ask qtec, you don't have to ask anyone else" determines our actions. ★★ How we support you ★★ As your strategic partner at hand, we assure that you may start or continue selling you products in the EU. In order to make sure to comply with the requirements as laid out in the MDR (MDD) and IVDR (IvD) we · Position ourselves as communication and coordination interface between you and your competent authority or notified body in case of CAPAs, complaints or any clarification needs. · Check your EU declaration of conformity · Check your technical documentation and have available a copy of it as required by MDR and IVDR · Check your conformity assessment procedure · And for the unlikely event that corrections are needed to your documentation or your product, we have the experts at hand to fix it