We are delighted and proud to announce that QAdvis Group has achieved ISO 13485:2016 certification. This is a major milestone and demonstrates our commitment to provide high quality consulting services and we are now better positioned to consistently meet and exceed our clients’ expectations.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
Regulatory requirements are a design input.