Airsonett has appointed yet another key person, Linda Berndtsson, who is the company’s new Director of Quality Assurance & Regulatory Affairs. As Airsonett will transfer the production from external manufacturing to in-house manufacturing Linda’s main task will be to build the quality system according to this strategic decision. She will be setting up operations for the QA and RA Department, and develop strategies for the regulatory work.
– Linda’s extensive experience of Quality Assurance & Regulatory Affairs in the medical technology industry, both in Europe and the U.S., will be a very valuable asset to us as we prepare for an international launch of our products Protexo and Opragon says Airsonett CEO Dan Kristensson.
Linda has worked for several years in managerial positions with Quality Management and Regulatory Affairs in medical device companies, most recently as Director of Quality Assurance & Regulatory Affairs at Biomet in Sweden. The American company Biomet is one of the world’s largest medical device companies in orthopedics.
Linda also has experience in worked in smaller companies, setting up new production to satisfy both European and U.S. regulatory requirements, which is a valuable asset when Airsonett now transfers its external manufacturing to manufacturing in-house. She has managed a number of product approvals for all classes of medical device products.
Moreover, Linda has been employed at HemoCue and she has an MSc from Lund University and several courses in QA & RA.
Airsonett is a research based medical technology company with a unique technology which leads the development of preventative and secondary preventative treatment of allergic asthma as well as management of airborne bacteria and virus contamination. Airsonett was awarded the title Sweden’s MedTech Company of the Year 2009. www.airsonett.com
For more information, please contact:
Dan Kristensson, VD, Airsonett AB, tel +46 431 402531, e-mail: dan.kristensson@airsonett.com