ISO 13485 documents form the foundation of a compliant medical device quality management system. This blog explains what ISO 13485 documentation includes, why it is critical for regulatory compliance, risk control, audits, and how it ensures product safety throughout the device lifecycle. https://13485certificationprocedures.wordpress.com/2025/12/31/what-is-iso-13485-documents-and-why-are-they-critical/