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IEC 62304 is an international standard that outlines the life cycle processes for medical device software, detailing the necessary activities and tasks to ensure safety and effectiveness. It emphasizes the integration of quality management and risk management systems, referencing ISO 14971 for risk management practices. The standard applies to both standalone medical device software and software embedded in medical devices, providing a framework for development, maintenance, configuration management, and problem resolution. Amendment 1 updates requirements related to legacy software and clarifies software safety classification.

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What is the difference between ISO 13485 and IEC 62304?

IEC 62304 and ISO 13485 often complement each other during medical software development. While IEC 62304 focuses on safety and risk evaluation of the specific software development processes, ISO 13485 provides a broader framework for quality management in the organisation.

What is the IEC 62304 standard?

IEC 62304 is an international standard medical device software that defines an agreed upon framework for processes that occur throughout the product lifecycle. IEC 62304 applies to medical device development when software is an integral component to medical device production.

What is the latest version of IEC 62304?

IEC 62304:2006 Medical device software Software life cycle processes. This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

Which of the following software are considered by IEC 62304 standard?

IEC 62304:2006 is considered a harmonized standard, meaning that it is recognized by the FDA and other regulatory agencies around the world. Note that this standard applies both to Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

What is the IEC 62304 safety classification?

IEC 62304 identifies three safety classes for medical device software: Class A: No injury or damage to health is possible. Class B: Injury is possible, but not serious. Class C: Death or serious injury is possible.

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What is the purpose of IEC 62304?

IEC 62304 incorporates a risk-based approach to guide software development intended for use in the health industry. It mandates the identification, assessment, and mitigation of risks associated with the software to ensure patient safety and device effectiveness. Software maintenance and changes.

What is the difference between IEC 62304 and EN 62304?

The requirements of IEC 62304 and EN 62304 are identical. Both, IEC 62304 and EN 62304, share the same genealogy and are well recognized software life cycle standards. The only difference is that they are promoted by two different standardization bodies.

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