In ISO 13485, a risk-based approach is a cornerstone for ensuring the effectiveness and compliance of a Quality Management System (QMS). This approach means that actions, controls, and evaluations be proportionate to the risks associated with specific processes,...
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...