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.
Covid-19 situation statement
In the current situation with Covid-19, increasingly stricter national measures are being implemented to protect public health. The health and well-being of our colleagues, clients, friends and families are our first priority Please be advised. QAdvis will to the outmost extent support our clients and deliver according to plans. We strive to offer […]
2019 was an exciting year for us at QAdvis!
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 […]
QAdvis wishes all our customers and partners a Merry Christmas and a Happy New Year!
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. Read our Diploma (Swedish). Link to the Swedish Childhood Cancer Foundation (Swedish).
October has been a busy month for us here at QAdvis
This week, Robert Ginsberg, QAdvis’s Chairman of the Board, was speaking at RMD in Brussels, our consultants have been participating as speakers at several events, including SARQA´s autumn meeting and MEDEA autumn meeting as well as participating in a meeting with Läkemedelsverket (Swedish Medical Products Agency). We have also hosted our new 2-day course […]
Finally released – Guideline for medical device SW i EU
We think that many of you have waited for the guideline for medical device SW in EU! “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” – Direct download link Link to European Commision A short introduction – 191014 Intro to the MDR & IVDR […]