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.
Meet QAdvis at RAPS in Washington
QAdvis is an exhibiter at the “The annual Regulatory Convergence in Washington” September 9th – 12th. If you are interested in scheduling meeting please send a mail to info@qadvis.com and we get back to you. Or come by and visit us in our Booth No. 338.
Robert Ginsberg speaker at RMD Europe 2017
Robert Ginsberg is a speaker at the 2nd European Symposium on The New Agreed Draft Regulations on Medical Devices. The event is in Berlin October 16th – 17th. Robert’s speech is about medical software regulation and compliance and is on the 17th at 2 pm. Read more at RMD Europe 2017
The new regulations on medical devices are now published in the Official Journal of the European Union
The texts are available following this link. The Medical Devices Regulation is identified as Regulation (EU) 2017/745. The In Vitro Diagnostic Medical Devices Regulation is identified as Regulation (EU) 2017/746.
Positive vote in the European Parliament on 5th April regarding EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)
The regulations will entry into force 20 days after publication in the EU Official Journal. Publication is expected to occur in May.
New member of our team – Emma Axelsson
Welcome Emma! Emma is located at our Stockholm office. Read more about Emma here.