ISO 13485:2016 governs Quality Management Systems for medical devices. In Saudi Arabia, where the healthcare and medical device sector is expanding, ISO 13485 is essential for safety, compliance, and global trade.
Importance in Saudi Arabia:
The Saudi Food and Drug Authority (SFDA) enforces rigorous standards. ISO 13485 ensures regulatory compliance, product traceability, and risk... https://qualitcert.com/iso-13485-certification-consulting-service-in-saudi-arabia/