“This is the rating for the videos, but for the course it is only one or two stars since it is not in line with auditing best practices. And also some of the questions are not clear which leads to confusion. I have sent an email as well about this.”
Hi Guido,
Thank you for your feedback.
As outlined in our email correspondence with you, and confirmed by our ISO 13485 expert, the course is based on ISO 13485 requirements for medical device auditing and does not include EMA/GxP-specific terminology such as “critical audit findings,” as these fall outside the scope of this standard. We understand that expectations may differ depending on regulatory background, and your input has been noted.
We’re always open to specific, actionable suggestions and will take your comments into consideration during future updates.
Kind regards,
The Advisera Team
