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Software Validation
 
The number of medical devices which are software-operated is rising sharply in recent years. Malfunction of the software may be life-risking. Therefore, software validation tests have become most demanding. The tests employed in Europe or the USA are based on standards issued by the FDA and IEEE (EN60601-1-4).
Every device which incorporates software has to comply with such standards, and present documentation of six steps. Testing procedure is very thorough, and includes the following steps:
  • Hazard/risk analysis document.

  • Software Requirements Specifications (SRS) document.

  • Software Test Plan, and Software Test Procedure Specification document

  • Software Test Reporting form.

  • Summary of test results.

  • Software quality assurance plan, and configuration management plan
Software validation projects can be an excellent training tool for your own software engineers, who can learn how to produce the required documents for future software projects
 
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