ISO 13485:2016 has become the new foundation for medical device quality systems. If you haven’t started your gap analysis, the time to start that transition is now. It is critical for medical device manufacturers and suppliers to begin implementing the standards of the revised ISO 13485:2016, as the allotted three-year changeover period may not provide adequate time for all organizations to transition.
What is ISO 13485 Quality Management System?
ISO 13485 quality medical 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.
