Welcome to RegSmart, Mats Artursson, senior consultant medical device

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!