The European Symposium on The New Agreed Draft Regulations on Medical Devices, organized by EAAR, takes place in Prague next week. QAdvis is represented among the speakers by Robert Ginsberg who will talk about medical device software and upcoming challenges within this field.
The new standard IEC 82304-1, Health software — Part 1: General requirements for product safety, has been published.
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.