In January 2023 you joined our team as senior consultant, medical devices.
What is your background, prior to joining RegSmart?
Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for eight years, as Assessor and Inspector, responsible for in-depth investigations of market surveillance cases with focus on medical device software and medical information systems.
I was involved in creation of Guidance on the MPA’s regulation (LVFS 2014:7) regarding National Medical Information Systems, and served as a member of IMDRF Software Working Group implementing four guidelines for Software as a medical device, SaMD,
In addition, I was Sweden’s representative in the EU Commission’s Software Working Group both as delegate and group leader, implementing guidelines for Medical device software and chaired a working group at the Swedish Standard Institute, SIS, implementing a standard for health applications.
Prior to working at Swedish Medical Products Agency, I have worked with development of medical device software in leading positions, at Siemens as well as St. Jude Medical, since 1985.
My scientific background is in the field of mechanics, I hold a Master of Science in Mechanics from Lund University.
What are your strengths? How do you contribute?
I have a very long and broad experience of medical device software both from medtech industry and from regulatory authorities. Since I know what the challenges are to both comply with regulations and to develop high quality software at reasonable cost I think I add competence to the RegSmart team.
What are you looking forward to at RegSmart?
I look forward to help our customers to put new, inventive and safe medical products to market with the ultimate goal to improve life quality of patient.
________________________________
Mats drug medical device software skills will be a great contribution to broaden the competence and expertise within the RegSmart team!