QAdvis has signed agreement with Lumito, developers of imaging techniques for both tissue in living organisms (in vivo) and tissue samples in laboratory environments (in vitro). Lumito intend to introduce their medical imaging solutions on the European market, and QAdvis will assist them in the regulatory work involved in implementing a quality management system and composing a technical file, which are both required for achieving CE markings.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.