White Paper

Tackling Medical Devices Challenges

The medical devices market is growing – and with growth comes a plethora of potential risks. The European Union’s Medical Devices Regulation came into force in May 2021, enacting new standards and rules by which medical device developers and manufacturers must abide. Coupled with the growth of software-based medical devices and the risks that accompany them, including cyber security and poor user experience design, it is essential for manufacturers to have a firm grasp of the hurdles they face.


In this white paper, learn more about: 

  • New requirements imposed by the EU’s Medical Devices Regulation 2021
  • Agile and how it can empower manufacturers during the device development process 
  • Tragic design and its consequences on the health of medical device users 
  • The expertise and support a partner like Critical Software can offer manufacturers


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