White Paper

The Role of Software in Medical Device Failures

It is increasingly rare to hear about a new medical device technology that doesn’t incorporate software in one way or another. In fact, technological innovation in medical devices is and will continue to be one of the key drivers for significant growth in the sector.

However, with progress comes the need to adapt. Software is now the top cause of medical device failures. Recalls can be extremely costly for manufacturers and other businesses involved in the production and maintenance of medical devices. With the broader advance of technology, issues such as how medical devices can be safeguarded against cyber-security threats play just as vital a role in their development and manufacturing as more traditional concerns such as the functional quality of the device.

This free white paper covers:

  • The evolution of medical device recalls
  • How software is driving the increase of medical device recalls
  • How manufacturers and operators of medical devices can safeguard against growing threats to the industry, including cyber-security hazards
  • How the Medical Device Regulation 2020 will tackle software safety issues and how it will affect manufacturers and operators
mdr and the role of software in medical device failures whitepaper