SOFTWARE AS MEDICAL DEVICE

Standalone Software as an Active Medical Device

With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IE...

Trustworthy Medical Device Software

This report summarizes what the computing research community knows about the role of trustworthy software for safety and effectiveness of medical devices. Research shows that problems in medical device software result largely from a failure to apply well-known systems engineering techniques, especially during specification of requirements and analysis of human factors. Recommendations to increa...

Medical Device Software as a Subsystem of an Overall Medical Device

Embedded software is a sub-system that needs to be integrated with the electrical and mechanical subsystems for a functional medical device to be developed and marketed. In order to be able to develop a medical device system through integrating its sub-systems, the complete system requirements should be known at the start of the project and managed throughout development. Software requirements ...

X. Medical Device Software Traceability

Software traceability is central to medical device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements including risks through the different stages of the software development and maintenance lifecycles. The regulatory bodies reques...

Towards high confidence medical device software