Medical Devices – Harmonizing Quality Management Requirements
- Topics:
- ISO Standards
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Overview: 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. However, 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. This article is about ensuring worldwide quality for medical devices, quality management and the medical field – A comparison between ISO 9001:2000 and ISO 13485 and Risk management and medical devices.
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Format: PDF | Size: 166KB | Date: Jul 2002 | Pages: 9
