Entries by Johnnie Dahlberg

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 […]

Very welcome Frederik Roos!

We are very happy that Frederik has joined our team. Fredrik will hands-on support our clients to safely and effectively navigate through the product development aspects in a regulated environment. He has 12 years of experience from the medical device industry with many leadership roles within international product development. Frederik holds a M.Sc. in Chemistry […]

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 […]