The compliag eQMS is an electronic quality management system from compliag AG for medical device manufacturers. It is artefact-based: each piece of information is stored once and serves as the basis for all documentation, decisions and reviews. The vendor targets ISO 13485, the EU MDR and the Swiss MepV. It comes in three levels, from core processes and work instructions to a rulebook fully tailored to the organisation. The extended level covers risk management, deviations (CAPA), product files, projects, a people register and an overview of IT infrastructure and applications. The vendor also mentions its own language model adapted to medical device manufacturing.
compliag AG is based in Zug, Switzerland; a GmbH in Vienna is listed in the imprint as its EU representation. Switzerland is not in the EU but is an EFTA country with an EU adequacy decision. The vendor mentions no foreign owner. The website says nothing about how the eQMS is delivered or where its data is stored, so ask the vendor.