Software can be a medical device itself, part of the technology stack for a device, part of the embedded electronic medical device, or can also be a mobile application with medical purpose.

To develop, and to put in practice, an effective software development process that takes a holistic view also on product risk management is a challenge on its own.

Process automation tools often should be integrated with each other to provide seamless support for medical software development.

Finding and implementing an effective tool solution that is capable of accomodating existing tools in an integrated manner for task management, requirement management, product risk management, verification and validation management, or for audit and CAPA management are among only a few of the many challenges we are faced with.

This presentation discusses these critical perspectives of tooling in the context of medical software development and medical audit and CAPA management.