Welcome Anna Wannberg! On March 28 you joined our team as senior consultant in medical devices.
What is your background, prior to joining RegSmart?
Well, I have a long regulatory background, for the last ten years at the Swedish Medical Products Agency, MPA. My main focus there was regulatory questions, such as borderline and classification, but also market surveillance for medical devices. I have served as Sweden’s representative in the EU Commission groups for MDD/MDR as well as IVD/IVDR.
Most recently my focus has been on implementing the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) from an authority perspective. I also worked with preclinical validations of clinical investigations for medical devices, and served as preclinical assessor reviewing market authorization applications for herbal medicinal products.
Prior to working at the Swedish Medical Products Agency, I worked at the Swedish Food Agency for three years, focusing on residuals of plant protection products. I have also worked with assessing applications for biocides at the Swedish Chemical Inspectorate.
My scientific background is in the field of toxicology and pharmaceutical science, and I hold a PhD in toxicology from Uppsala University.
What are your strengths? How do you contribute?
My strong regulatory background makes me able to guide through a range of different regulatory frameworks to find the most suitable solution, taking the aim of the product and its principle of action into account. For medical devices, I have vast experience regarding classification.
As a person, I am really enthusiastic about learning new things, working as a team member and to share my knowledge and perspectives.
What are you looking forward to at RegSmart?
I am looking forward to supporting customers in finding and fulfilling relevant regulatory requirements, and contributing to scientifically sound products on the market.
Anna´s experience within medical devices will be a great contribution to broaden the competence and expertise within the RegSmart team!