Software validation for medical device manufacturing

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...

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...

Medical Device Software Development - A Perspective from a Lean Manufacturing Plant

Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasi...

Demo Abstract: A Platform for Implantable Medical Device Validation

Designing bug-free medical device software is difficult, especially in complex implantable devices that may be used in unanticipated contexts. In the 20-year period from 1985 to 2005, the US Food and Drug Administration’s (FDA) Maude database records almost 30,000 deaths and almost 600,000 injuries from device failures [8]. There is currently no formal methodology or open experimental platform ...

Towards high confidence medical device software