The Role of Software in Healthcare - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations

The RA QA Café

What are the differences between Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD)? In this third episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Lezlie Hynes (Principal Quality Consultant) and Monica R. Montanez (Principal Product Development Strategist).

During the discussion, they delve into the differences between SiMD and SaMD, as well as FDA criteria deemed important during evaluation of the safety and effectiveness of device software with one or more device functions.

“I get a lot of questions related to the FDA guidance document. Most sponsors do not really take that guidance document seriously and the FDA does. Every element in that guidance document needs to be considered. ” – Monica Montanez, Principle Product Development Strategist

Discussion topics include:

• What criteria are utilized to classify a device as either SiMD or SaMD?
• Are certain regulatory agencies taking the lead on future regulations?
• How can we better understand digital health trends?