Regulation (EU) 2017/746 of the European Parliament and of the Council
of 5 April 2017
on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
Legislative Act Regulations and Annex textbook. Printed and ring-bound with plastic cover.
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.
MDR Book 