IEC 62304 is an international standard that defines the lifecycle processes for medical device software. It establishes requirements for the development, maintenance, and risk management of software used in medical devices, ensuring patient safety and regulatory compliance.
The standard is harmonized with FDA regulations and is required for medical device software in many jurisdictions worldwide. It provides a framework for software development that integrates with quality management systems and risk management processes.
No injury or damage to health is possible
Non-serious injury is possible
Death or serious injury is possible
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