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IEC 62304 applies to medical device development when software is an integral component to medical device production. It defines the software lifecycle when the software stands alone as a medical device (commonly referred to as software as a medical device, or SaMD), is a component of a medical device, or is used in the production of a medical device.
IEC 62304 is an internationally harmonized standard for medical device software lifecycle processes, recognized by FDA and other regulatory agencies across the world. IEC 62304 provides guidance to the manufacturer on planning, development, and postmarket surveillance activities for medical device software to ensure companies are in compliance with both U.S. and other international regulatory requirements.
An earlier release of IEC 62304 was less clear, but a 2006 amendment to the standard clarifies the requirements. IEC 62304:2006 provides guidance to manufacturers on how to identify hazards that could arise from software failure or defect, in order to properly classify the risk of a medical device. Based on the device risk classification, IEC 62304 provides guidance for risk control measures that must occur throughout the life cycle of that particular device.
IEC 62304 identifies three safety classes for medical device software:
This classification scale helps the manufacturer to identify the safety-related processes needed throughout the lifecycle of the medical device software. The applicable requirements are specific to the development and coding, release, and maintenance of medical device software. They are codified in the components of IEC 62304.
IEC 62304 for medical device software development delineates components into five clauses, numbered 5 through 9.
The best approach to medical device software development is risk-based, structured and methodical. Traceability throughout the lifecycle of medical device software is key to ensure compliance with IEC 62304.
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