QAdvis presentation

QAdvis AB is based in Sweden with two offices – Lund and Stockholm. The company was founded in late 2013 by Robert Ginsberg, Nils-Åke Lindberg and Kurt Högnelid. During 2014 many long-term business and partnership agreements have been set up with Medical Device and In Vitro Diagnostic Medical Device Manufacturers.

Since its founding, we have conducted many expert assignments with a significant number of clients being located outside Sweden.

Our experts are actively participating in several national and international standardization committees and EU work groups.

Nils-Åke Lindberg has been working in the international medical device industry for 30 years and has a thorough knowledge of quality assurance management and regulatory affairs. He has conducted numerous internal, external and supplier audits and works regularly with Competent Authorities and the Food and Drug Administration in the United States. He is a participant of SIS/TK355, Medical Quality Management Systems and of EAAR, European Association of Authorized
Mail to Nils-Åke Lindberg

Robert Ginsberg has more than 30 years of software development experience, with 24 years in medical device software. He has participated in more than 20 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.
Mail to Robert Ginsberg