The Value of Device Testing in Medicine

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The Value of Device Testing in Medicine

Today, most industries rely heavily on digitized devices, and healthcare is no exception. Medical specialists use various software programs and electronic tools for accurate diagnostics and effective treatment. For leading clinics, technological solutions are as important as the expertise of medical staff.

Reasons to Invest in QA Services and Software

Healthcare organizations need to be aware of the risks when shifting certain medical operations from human to digital resources. Modern tools facilitate the work of clinicians, but the tradeoff is loss of control over the accuracy and safety of treatment. Wrong diagnoses and irreversible damage to patients’ health hang in the balance. Every year, digitized tools become more complex and their internal processes become less understandable to humans.

No clinic should introduce innovative devices and software without properly testing them first. The rapid spread of automated treatments have made quality assurance a gold standard in modern medicine. Special regulators have appeared all over the world to ensure that every device used in healthcare is safe and performs as claimed by the manufacturer.

Today, both clinics and patients recognize the value of QA in the healthcare industry. With a growing number of medical device recalls, fundamental testing is no longer an option for software vendors. If they cannot provide quality assurance certificates, their product will simply not be allowed on the market, and any attempt to sell it will be illegal. 

How Medical Device Testing Works

Rather than waiting to test software until after it is completely developed, manufacturers should keep quality standards and project requirements in mind from the initial draft through the entire development process. By detecting vulnerabilities and fixing bugs in the early stages, they can avoid having to make fundamental changes to the finished  product, which is usually costly and laborious.

It is also important to ensure that the medical device is compatible with devices and software already in use at a clinic. Its resistance to high loads should be tested, along with outage protection to ensure safe operation under any conditions.

Methods for Testing Healthcare Device Software

Testing strategies are developed based on the purpose of the software, specifics of the development process, and the standards and regulations that apply to it. Common testing methods include:

  • Automated testing accelerates and increases the accuracy of the testing process. Testing software simulates the environment for which medical software is intended.
  • White-box testing is focused on operations performed internally in healthcare devices.
  • Functionality testing scrutinizes the external performance of software and its interaction with other systems. Different scenarios are simulated to check the response of medical devices.
  • Software and hardware validation analyzes the performance of medical software on hardware similar to that used in a clinic.
  • Verification involves collecting the device’s characteristics and performance metrics and comparing them with parameters established at the project launch stage.
  • Compatibility and error handling testing is performed to determine whether the device correctly receives, processes and transmits data, and whether it can endure critical situations like outages and malfunction of related devices, and notify medical workers in a timely manner.

Conclusion

Thorough and comprehensive medical device testing is critical to the efficiency and safety of healthcare services. It must be performed throughout the entire software development cycle, keeping in mind standards and regulations, individual requirements of the clinic that will use the product, and compatibility with other devices in the chain.