Qualix is a company specialized in Quality and Regulatory affairs for (in vitro diagnostic) medical devices. We support organizations active in the (in vitro diagnostic) medical device field with the following services: -Set up, implement and/or modify Quality Management System -Regulatory file writing, coordination and submission -Outsourced Quality /Regulatory affairs management (QA management ad interim) - Audit assistance (internal audits, notified bodies audits, competent auth, ...)