Question 1

Is this a software development course?

Accepted Answer

No. It focuses on clinical and regulatory planning for healthcare software.

Question 2

Can a wellness app be considered SaMD?

Accepted Answer

That depends on its intended purpose and claims; the course explains how to assess this distinction.

Question 3

Will this course certify my software as a medical device?

Accepted Answer

No. It provides training, not product certification or regulatory approval.