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Strengthening the QA&RA team!

We warmly welcome our new colleague Lisa Lundberg Dellenvall in joining the QA&RA consultant team. Lisa has a Master’s degree in Chemistry and brings a wealth of experience from the international medical device industry. In particular, she is very well versed to bring clarity and stability in potentially complex design control processes. Further, her expertise […]

Midsummer weekend and Sweden’s summer holiday

Hello, this year’s Midsummer weekend, and the start for Sweden’s summer holiday season is just a few days away. For many of us, both working and everyday life became completely different, starting from March 2020. QAdvis has since then conducted its operations almost entirely on a remote basis. Different solutions made it possible to follow […]

Date of Application for the Medical Device Regulation

Today, May 26, 2021, is the Date of Application for the Medical Device Regulation (MDR 2017/745), one year later than initially planned. Over the past years, focus has been on the new regulatory requirements for all economic operators, and the pieces are finally starting to come together. For manufacturers, developing the technical documentation and implementing […]