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.
Our services include:
• Quality management support
• System development
• Quality and regulatory consulting
• European Authorised Representation
As compliance in the MedTech field is governed by rigidly specific requirements, developing and using a reliable quality management system is key to fulfilling and maintaining compliance. We support you in this process, using best practices based on three decades of projects in this field.
QAdvis is an active member of the European Association of Authorised Representatives, offering support and legal EU representation for non-EU companies who want to enter the European market.
We also offer support for foreign businesses entering the US market, conducting mock audits, Quality System Regulation assessments, evaluations and collecting information required for FDA applications.