When you think about standards for medical device software, IEC 62304 is probably the first one that comes to mind. If you develop software for medical devices, this is definitely the standard you should look into.
Less known is IEC 62304's bigger brother, the IEC 82304 "Health software — Part 1: General requirements for product safety" which expands on the IEC 62304.
So what are the main differences? When shall I use which standard?
IEC 82304 targets a larger range of device types than IEC 62304. IEC 82304-1 targets any kind of software, which directly or indirectly has an effect on health, known as "health software" in the standard.
In contrast, IEC 62304 only targets software with medical intended use.
Examples of device types that are in the scope IEC 82304 but not IEC 62304:
IEC 82304 is intended for standalone software and not as IEC 62304, software embedded in medical devices or embedded in devices with specific hardware.
Software running on PCs, Server or Mobile Devices on a general purpose Operating System are in the scope of IEC 82304.
As mentioned, IEC 82304 expands on IEC 62304 and addresses both additional Design Controls and requirements on expanded parts of the Product Life Cycle.
It includes Product Use Requirements as well as Product Validation Plans and Reports. It specifies requirements on Product Identification and Instructions For Use as well as Post-market activities.
IEC 82304 references IEC 62304 for software development and maintenance, i.e. on a software level.
The Aligned Elements IEC 82304 configuration is a superset of the IEC 62304 configuration. It expands the IEC 62304 configuration with Product Use Requirements and Product Validation Tests. It has been tuned to automatically take care of most of the involved quality checks, making sure that the required tasks and actions are sufficiently covered.
The Aligned Elements IEC 82304 configuration contains:
The Aligned Elements IEC 82304 supports documentation management of:
The Aligned Elements IEC 82304 Configuration can be downloaded here.