Expert knowledge for digital decisions
How often should practices test their medical software?
Short answer
Importance of Test Frequency for Medical Software
Regular checks of medical software are crucial for practices to ensure the safety and functionality of the systems. Medical software must not only comply with current legal requirements but also operate reliably to avoid endangering patient care.
Legal Requirements
In many countries, there are specific legal requirements governing the validation and testing of medical software. These regulations may vary but often include requirements for regular software checks to ensure compliance with established standards. Practices should inform themselves about the applicable regulations in their country and ensure compliance.
Regular Tests
The recommended frequency for testing medical software is generally at least once a year. These regular tests help identify potential errors or security vulnerabilities before they lead to serious problems.
Tests After Changes
In addition to regular tests, practices should also conduct tests after any significant changes to the software. This includes:
- Software updates
- Introduction of new features
- Changes in workflows
These tests are essential to ensure the software continues to function properly and that new features work as intended.
Conclusion
The frequency of testing medical software should be tailored to the specific circumstances of the practice. In addition to annual tests, it is important to conduct tests after significant changes to ensure the safety and efficiency of the software. Practices should regularly inform themselves about current legal requirements and ensure these are considered in their testing strategies.
Key facts
- Recommended Test Frequency
- at least once a year
Sources
All external claims are backed by traceable sources.-
01
IEC 62304:2006+A1:2015 – Medical device software life cycle processes International Electrotechnical Commission (IEC)
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02
Verordnung (EU) 2017/745 über Medizinprodukte EUR-Lex / Europäische Union