Broadly,ISO/TC 210,Quality management and corresponding general aspects for medical devices,defines its scope as:"Standardization of requirements and guidance in the field of quality management for medical devices."The field is extensive and rapidly evolving through technological advancements,and the demands run high for medical devices to aim for the utmost in quality for health and safety.But not all national quality systems are the same,and medical devices are highly regulated in virtually all markets.International Standards can help in a number of ways.The authors describe how ISO/TC 210 is undertaking the development of standards with the goal of ensuring quality worldwide for medical devices,and specifically two major thrusts of activity:the global harmonization of quality system requirements and risk management.
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