Question 1

Is this course only for regulatory professionals?

Accepted Answer

No. It is designed for product, engineering, clinical, quality and regulatory teams.

Question 2

Will it teach me to prepare a complete CER?

Accepted Answer

It introduces clinical-evaluation principles; it is not a substitute for device-specific CER development.

Question 3

Is prior device experience required?

Accepted Answer

No. Basic healthcare or product-development knowledge is helpful but not essential.