The answers are revealed, and they may surprise you.
In Part I of our ISO 13485 test, see how much you know about the basics of the standards.
Is your risk management process fully operational right now?
Getting through the complex maze of regulatory requirements can be an overwhelming process for any medical device company.
Fewer resources and more requirements are hindering the process.
A review of changes made to the standard published earlier this year.
The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.