Medical Devices Regulation Countdown
(EU) 2017/745 (MDR)
All medical devices need to comply with a number of rigidly specific requirements from national regulatory bodies. Read more.
As medical device companies grow, significantly change their organization or evolve into several sites, the need often … Read more.
We know, from extensive experience, that compliance goes hand in hand with productivity. Don’t fall into the trap of … Read more.
Our team of senior software consultants can assist you in achieving compliance and high productivity in your software … Read more.
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.