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...
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...