Software testing in the medical sector

Software testing in the medical sector

Reasons why a company should test its software vary hugely according to the nature of the software and what it was developed for.

However, this does not deny the fact that testing remains crucial for all types of software. When choosing a testing service, companies focus on different aspects

In this article we are going to speak about risk-based testing (RBT). It is intended to consider risks of the software as the main factor in making decisions during all phases of the test process.




What makes medical software testing different?


            Other types of software                  Medical software
Testing is functional: Does the software do what it should do?

Software is functional: Does it do what it should do?

Software is safe

Software is effective

How does the law regulate medical software testing?


We chose to mention examples of international standards to better explain this issue


Standard ISO 13485: Quality management system


  • According to the standard ISO 13485, you should verify and validate test plans.
  • As a medical software developing company, you should take into consideration how to verify and validate medical devices that connect with medical devices.


Standard ISO 1491: Risk management standards for medical devices


  • The purpose of ISO 14971 is to set the main lines for developing companies in order to help them set a medical management process to identify risks and evaluate them.
  • According to ISO 14971, the manufacturer shall set risk control measure, and verify their effectiveness.


International standard EN/ICE 62304: Evaluates design, management and safety


EN/ICE 62304 stipulates that the manufacturer should set a safety class to software system and take into consideration the potential of a risk that would cause an injury to the patient or to the user of software.

Potential hazards and risks are classified as follows:

  • Class A (no injury or damage to health is possible).
  • Class B (non-serious injury is possible).
  • Class C (death or serious injury is possible)




The medical sector is full of risks and dangers. When launching an IT health business, companies find themselves in an adventure where almost everything is unknown. A few recommendations might help you in this case:

  • Developing a great deal of knowledge about legal matters before developing or testing existing software
  • Plan the investment in equipment and procedure in a way that is compliant with the law and international standards.
  • A coherent commercial strategy for the development of software while considering a cross-border basis.



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