The International standard IEC 62304 is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. As it is harmonised by both the European Union and the US, it can be used as a benchmark to comply with regulatory requirements from both these markets.
The IEC 62304 standard calls out certain cautions on using software and spells out a risk-based decision model on when the use of a certain software is acceptable. It also defines the testing requirements for software to support the reasons on why such software should be used in the first place.
What is IEC 62304
The term “medical devices” is applied to all systems and devices used for diagnosis, treatment or monitoring of patients. There are statutory specifications and standards for medical devices and all software that goes into them must comply to those. However, there was no standard that would specify the risk management process for software. This is where IEC 62304 comes into play.
The standard focuses mainly on the software development process and defines the typical activities of the system life cycle such as planning, design, requirements analysis, implementation and testing. The standard describes in detail all process and documentation requirements for each phase of software development. The IEC 62304 risk management process requires that criticality is always evaluated and that the extent to which the software could be the cause of a hazardous situation is known. This must be documented thoroughly as well. But what kind of software is actually dedicated to work with IEC 62304?
Software for IEC 62304
Software is becoming one of the integral parts of medical device technology. Establishing the safety and effectiveness of a medical device containing software requires knowledge of what the software is intended to do and demonstration that the use of the software fulfils those intentions without causing any unacceptable risks. All software that goes into medical devices must be compliant to IEC 62304 standards and requirements. Software is now formally classified as a medical product, which means that it is recognised as potentially hazardous and needs to be properly assessed.
Apart from software that actually runs all medical devices, there is also software designed to help software developers with employment of all the rules and restrictions mentioned in the IEC 62304. It works in the same way as software for ISO compliance would – it gives you clear instructions and helps to make the newly developed software up with all standards.