Saudi Arabia’s growing healthcare sector demands medical device standards: ISO 13485:2016 outlines required Quality Management Systems (QMS) for safety, traceability, and regulatory compliance in medical device production. Why ISO 13485 Matters SFDA Approval: Required for registration and market entry. Product Safety: Reduces defects and improves ongoing stability. Traceab... https://qualitcert.com/iso-13485-certification-consulting-service-in-saudi-arabia/