EN 62304:2006+A1/2015


Software is regularly an indispensable piece of medical devices innovation. Building up the security and viability of a medical devices containing software requires information on what the product is expected to do and exhibit that the utilisation of software satisfies those aims without containing any inadmissible risk. This standard furnishes a system of lifecycle processes with exercises and undertakings essential for the protected plan and upkeep of medical devices software.

This standard gives prerequisites to every life cycle process. every lifecycle process comprises of set of exercises , with most exercises comprising of a bunch of errands .

As a fundamental establishment it is accepted that medical devices software is created and kept up with inside a quality management system and risk management process. The risk management process is very well addressed by the international standard ISO 14971 . Along these lines IEC 62304 utilises this benefit essentially by a regulating reference to ISO 14971. So minor extra risks the board prerequisites are required for software ,particularly in the space of ID of contributing software factors identified with risks. these necessities are summed up and caught in clause 7 as the software risk management process .  Whether software is a contributing factor to a hazardous situation, it is determined during the hazard identification activity of the risk management process.

Hazardous situations that could be indirectly caused by software need to be considered when determining whether software is a contributing factor . The decision to utilise software to control risk is implemented during the risk control activity of the risk management/assessment process. The software risk assessment process required in this standard has to be embedded in the device risk assessment/ management process as per ISO 14971.  The product improvement process comprises of various exercises.

Since numerous episodes in the field are identified with administration or upkeep of medical devices frameworks including unseemly software updates and overhauls, the product support process is viewed as significant as the product advancement process. The software upkeep process is basically the same as the product improvement process.


1 – Software development planning
2 – Software requirements analysis
3 – Software architectural design
4 – Software detailed design
5 – Software unit implementation and verification
6 – Software integration and integration testing
7 – Software user acceptance testing
8 – Releasing of software


1 – Establishment software maintenance
2 – Problem and modification analysis
3 – Software architectural design
4 – Software detailed design
5 – Software unit implementation testing
6 – Software integration and integration testing
7 – Software system design
8 – Software release