ISO 13485 & SFDA QMS Requirements
Quality Management System requirements under the SFDA — ISO 13485, the Saudi SFDA.MD/GSO ISO 13485 standard, and who must be certified.
SFDA Conformity Assessment Bodies (CABs)
SFDA-accredited Conformity Assessment Bodies (CABs) — who they are, which device classes require CAB certification, and how to find an approved CAB.
SFDA Inspections & Audits
SFDA inspection authority — when SFDA inspects manufacturing sites, what to expect, and how to respond to SFDA non-conformity findings.
Core QMS Requirements
Core Quality Management System requirements for medical device establishments in Saudi Arabia — management responsibility, design controls, CAPA, complaint handling, and more.