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IEC62304, the reference standard for medical device software life cycle

Software lifecycle for medical devices: what is IEC62304 and how is it used in medical device compliance?

The life cycle of a product concerns the process from the product idea to the market exclusion. This concept is also applied to software as a medical device that must be developed and manufactured in accordance with specific requirements for safety and performance.

IEC 62304 is the reference standard for the entire life cycle of the medical device software (SW) and describes a common framework of basic software processes, including development, maintenance and risk management.

It clearly outlines the steps to provide a safe and robust SW for a medical device that can perfectly fit with different project management methodologies, such as Agile.
Indeed, according to our quality management system, the Henesis’ SW development team is working in line with the requirements of the IEC 62304 but following an evolutionary life cycle process, emphasizing close collaboration between the SW development team, customers and stakeholders.