Hermine Redl, Office Manager, and Bing Wu, E.A.R. Manager and Quality and Regulatory Consultant at our Kista office and Caroline Ehrenborg, Quality and Regulatory Consultant at our Lund office are all very welcome new members on our team.
We have taken part in a number of conferences this year, including RMD USA, RMD Europe, RAPS USA and Swedish Medtech Summit 2019, in coordination group meetings with Swedish Medical Products Agency (LMV) and Swedish Institute for Standards (SIS) and we have participated in standardization work groups within the fields of cybersecurity, quality management systems and risk management (including IEC/TR 606001-4-5, IEC 80001-5-1, TK355). We have given presentations and we have been trade fair exhibitors, actively participating in all of these events to keep up to date on the developments and latest news within regulations, standards and guidelines.
Our breakfast seminars and courses, both our own and those that we have arranged in collaboration with Swedish Medtech and Intertek, have been popular events.
We refrain from physical christmas gifts and choose to support the Swedish Childhood Cancer Foundation (Barncancerfonden) in their effort to prevent and combat cancer diseases in children.
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.