GB/Z 42217-2022
ActiveMedical device —Validation of software for medical device quality system
医疗器械 用于医疗器械质量体系软件的确认
Application Summary AI generated
This standard specifies requirements for validating software used within a medical device manufacturer's quality management system, such as software for document control, complaint handling, or production management. It applies to any software that automates or manages processes required by ISO 13485 or similar quality system regulations, ensuring the software performs as intended and does not compromise product safety or regulatory compliance. The standard is used by medical device manufacturers during software selection, implementation, and periodic review to demonstrate that quality system software is suitable for its intended use.
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