ISO 13485 is an international standard developed by the International Organization for Standardization (ISO) that specifies requirements for quality management systems (QMS) for organizations involved in the design, production, installation, and servicing of medical devices. The standard emphasizes risk management, documentation, traceability, and regulatory compliance throughout the product lifecycle to ensure the safety and effectiveness of medical devices.
In the context of maintenance management, ISO 13485 may require organizations to properly document and control maintenance activities related to equipment used to manufacture or repair medical devices.
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