Ask Me Anything session: Software as a Medical Device

In this Ask Me Anything session, Mika Siitonen, Medical Development Manager at Labquality, answers key questions around Software as a Medical Device (SaMD) and clarifies the regulatory complexities of this fast-evolving field.

You’ll learn:

• The difference between SaMD, SiMD, and MDSW

• How to navigate the regulatory classification and requirements

• What’s expected in terms of QMS and validation for SaMD

• Practical challenges in development and compliance

• Common misconceptions and how to avoid them

This session is a must-watch for professionals working in medical device software, QA/RA, and regulatory affairs.