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.
Is UDI for medical devices as complicated as it seems?
Purpose of implementing a device identification system is to improve patient safety by making the traceability of devices more efficient and simplify a FSCA (Field Safety Corrective Action) e.g. recall of devices. In parallel, the post-market safety-related activities for devices will also be more robust and allow a better monitoring by the competent authorities. UDI, […]
Welcome onboard Sneha Bangalore
After 4 months of internship at QAdvis we are now happy to welcome Sneha to the QAdvis Team as a consultant. Sneha has during her internship gained an overview insight of Quality and Regulatory consulting and will now continue to act as support within certain projects. Sneha contributes with her positive attitude, a quick understanding […]
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 […]