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.
Mikael Karlsson has joined QAdvis!
We are very pleased to welcome our new colleague joining our QA&RA consultant team. Mikael has a master’s degree and over 20 years of experience in product development and production from innovative companies within Life Science and Space Technology. Over the last 12 years he has been focusing on Quality Assurance and Regulatory Affairs management […]
We are pleased to share some great news about the further strengthening of our Quality and Regulatory team.
We welcome Krishnadev Moothandassery Ramdevan who has just started as QA&RA consultant, based in our office in Stockholm. He will be a great addition to our team. Krishnadev has his master’s degrees in Medical Engineering from KTH, Stockholm. He has a background in software development and testing for pharmaceutical and life science companies, with an […]
Various interesting events during springtime
Our collaboration with Swedish Medtech has been successful since 2018 and we are proud to participate in the Swedish Medtech Regulatory Summit 2021. Senior Quality and Regulatory consultant Anna-Karin Areskog will make a presentation on the latest status regarding IVDR implementation. QAdvis consultant will during the spring be part in several presentations in the MedTech4Health […]
Update on situation with Covid-19, January 2021
The ongoing situation with Covid-19, the further extended time range on recommendations to work from home, as well as the maximum allowed number of participants in meetings/events, maintains our limitations regarding visitors in our office premises. In order to eliminate any risk of QAdvis hosted events, keeping both employees, clients and colleagues protected from possible […]
IEC TR 60601-4-5 is now published
– an important step in the Cybersecurity work
Today we have the pleasure to announce that the cybersecurity technical report IEC TR 60601-4-5 has been published. The not so short title of this report is: Medical electrical equipment – Part 4-5 Guidance and interpretation – Safety related technical security specifications for medical devices This technical report contains concrete cybersecurity requirements to be implemented […]
– an important step in the Cybersecurity work