Quality/regulatory support
STRATEGY AND DEVELOPMENT
Qualix
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, ...)
[Product Trajectory] - IPR issues [Product Trajectory] - Product development & Roadmap
Health
[INDUSTRY] SMEs [INDUSTRY] Midcaps [INDUSTRY] Large Enterprise [RESEARCH] Research and technology organisations 
Support organizations active in the (in vitro diagnostic) medical device field with the following services: - Set up, implement and/or modify Quality Management System (ISO13485) - Regulatory file writing, coordination and submission - Outsourced Quality /Regulatory affairs management (QA management ad interim) - Audit assistance (internal audits, notified bodies audits, competent authority inspections - Training