QAdvis AB is based in Sweden with two offices – Lund and Stockholm. The company was founded in late 2013 and today has about 25 senior and expert consultants supporting clients worldwide within medical devices and in vitro diagnostic medical devices.
We offer a complete range of multidisciplinary quality and regulatory services, including European Authorized Representation for non-EU manufacturers.
Our consultants are actively participating in several national and international standardization committees and EU commission working groups.
Key contact – Lund Nils-Åke Lindberg has been working in the international medical device industry for over 30 years and has a thorough knowledge of quality assurance management and regulatory affairs. He is an active participant of ISO/TC210, SIS/TK355, Medical Quality Management Systems and board member of EAAR, European Association of Authorized Representatives. Mail to Nils-Åke Lindberg
Key contact – Stockholm Robert Ginsberg has more than 30 years of software development experience, with 26 years in medical device software. He has participated in numerous audits involving the Food and Drug Administration, the Medical Device Directive and others, is a Certified Lead auditor (ISO 13485 & QSR), co-author of IEC/ISO 62304, 82304, 80001-1, 80002-1, 80002-2 and a working member of Cenelek TK-62.