Entries by Johnnie Dahlberg

Thanks to Swedish Medtech Regulatory Summit

Last week we were present at the Swedish Medtech Regulatory Summit. A big thank you to Swedish Medtech for a great event and thank you to all of you visiting our both on site and digital as well as listening to Cecilia Emanuelsson and Cilla Lundevall. If you would like to know more or if you have […]

… with BSI regarding MDR-Application Process

MDR Application Process – What do you need to know? QAdvis have invited Magnus Olla from BSI in Sweden to give us some “need-to-know” when you plan for your MDR-Application. Magnus will also talk a about the new regulation 2023/607 amending regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical […]

Extension of the MDR transitional period and removal of the “sell off” periods

European commission has now official published the Q&A on practical aspects related to the implementation of regulation 2023/607 amending regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.  The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to […]

Come and Meet Us at the Regulatory Summit on March 30th

We are present at Swedish Medtech’s Regulatory Summit on March 30th. Meet us here if you want to know more about what we do, or if you just want to have a quality and regulatory chat. And take the chance to listen to two of our most experienced consultants, Cecilia Emanuelsson and Cilla Lundevall.