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Mikael Karlsson Email
Senior Quality & Regulatory Consultant . QAdvis AB
Kista,
LocationPrimary Email
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Employees:
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$9.5MAbout
QAdvis is a MedTech consulting company within Quality, Regulatory and Clinical evaluations. We are a longtime trusted service provider for the medical device and in-vitro diagnostic device industry. Our 20 senior and expert consultants support clients both in Europe and worldwide. QAdvis offers a complete range of multidisciplinary services starting from strategic regulatory expert advice to complete outsourced QA&RA management. In the regulatory field we support companies to receive market clearance in Europe, USA, and worldwide, including areas such as CE-marking, MDR/IVDR/MDD/IVDD, risk management, regulated software and clinical evaluations. We compile and submit national device registrations like 510k, PMA, CE-marking/Technical Files. We manage recalls and warning letter situations, training sessions, provide European Authorized Representation for non-EU based companies, and more. 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 very experienced and 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 offices are located in Stockholm and in Lund, Sweden.QAdvis AB Address
Färögatan 33Kista, null