We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.
Extension of the MDR transitional period and removal of the “sell off” periods/in News from QAdvis, startpage /by Johnnie Dahlberg
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/in startpage, News from QAdvis /by Johnnie Dahlberg
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.
Welcome Linda Lindberg!/in News from QAdvis, startpage /by Johnnie Dahlberg
We are happy to announce that QAdvis has a new consultant in our team, a warm welcome to Linda Lindberg! Linda has over 15 years of experience in product development and bringing new products to the market within the medical device, in-vitro diagnostic, biotech and pharmaceutical industries, both from start-ups and large international companies. She […]
QAdvis Collaboration with Swedish Medtech Continues in 2023/in News from QAdvis, startpage /by Johnnie Dahlberg
QAdvis will remain as a Swedish Medtech networking partner in 2023 and together we are offering up-to-date courses and seminars addressing current topics within the medical device quality and regulatory landscape. You can meet us at Swedish Medtech’s Regulatory Summit on March 30th if you want to know more, or if you just want to […]
Voting Complete – extension of MDR transition times and removal of sell-off period for devices from MDR and IVDR/in News from QAdvis, startpage /by Johnnie Dahlberg
The EU Parliament has adopted the MDR amendment proposal, February 16th, and removed the sell-off date for both medical devices and in-vitro medical devices. The amendment will come in force upon publication in the official journal, which is expected in the coming weeks. The European Parliament has on February 16th adopted the Commission proposal for […]