| ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System. It provides a practical foundation for medical device companies to address Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical device products. ISO 13485 adapts the ISO 9001 process model of Plan, Do, Check, Act designed for regulatory compliance and is more prescriptive by requiring a more demanding quality management system and documentation. |
