Design developer - 21 CFR 807 - do we need to register?
21CFR820 requirements for Foreign Exporter?
Could anyone advise if a Foreign Exporter only needs to have their establishment registered with the FDA, or would they need to ensure they have processes in place to follow FDA regulations for medical devices (21CFR820 specifically) as well?
What is the significance of UDI date requirements for Class 1 devices?
ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820?