Clinical evidence is needed for all medical devices, irrespective of device class or legislation (MDR or IVDR) … Read more
Non-European manufacturers of medical devices
without an establishment within the European Union are required … Read more here!
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.