Guidance for Off-The-Shelf Software Use in Medical Devices
Guidance for Off-The-Shelf Software Use in Medical Devices
Guidance for Off-The-Shelf Software Use in Medical Devices
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• Describe test<strong>in</strong>g, verification and validation of the OTS <strong>Software</strong> and ensure it isappropriate <strong>for</strong> the device hazards associated with the OTS software. (See Note1)• Provide the results of the test<strong>in</strong>g. (See Note 2)• Is there a current list of OTS <strong>Software</strong> problems (bugs) and access to updates?Note 1: FDA recommends that software test, verification and validation plans identify theexact OTS <strong>Software</strong> (title and version) that is to be used. When the software is testedit should be <strong>in</strong>tegrated and tested us<strong>in</strong>g the specific OTS <strong>Software</strong> that will be deliveredto the user.Note 2: If the manufacturer allows the use of the medical device with different versions ofOTS <strong>Software</strong> then the manufacturer should validate the medical device <strong>for</strong> each OTS<strong>Software</strong> version.6. How will you keep track of (control) the OTS <strong>Software</strong>? - An appropriate plan shouldanswer the follow<strong>in</strong>g questions:• What measures have been designed <strong>in</strong>to the medical device to prevent the <strong>in</strong>troduction of<strong>in</strong>correct versions? On startup, ideally, the medical device should check to verify that allsoftware is the correct title, version level and configuration. If the correct software is notloaded, the medical device should warn the operator and shut down to a safe state.• How will you ma<strong>in</strong>ta<strong>in</strong> the OTS <strong>Software</strong> configuration?• Where and how will you store the OTS <strong>Software</strong>?• How will you ensure proper <strong>in</strong>stallation of the OTS <strong>Software</strong>?• How will you ensure proper ma<strong>in</strong>tenance and life cycle support <strong>for</strong> the OTS <strong>Software</strong>?2.2 OTS <strong>Software</strong> Hazard AnalysisA comprehensive risk management approach <strong>in</strong>cludes hazard analysis and mitigation thatcont<strong>in</strong>ues iteratively throughout the life of the product. <strong>The</strong> manufacturer is expected to per<strong>for</strong>man OTS <strong>Software</strong> hazard analysis as a part of a medical device (system) hazard analysis.OTS <strong>Software</strong> failure, malfunction, or misuse may present a hazard to the patient, operators, orbystanders. Figure 2-1 (next page) summarizes the typical hazard management and mitigationprocess which would <strong>in</strong>clude a hazard analysis of the OTS software component.<strong>The</strong> submission should <strong>in</strong>clude the follow<strong>in</strong>g <strong>in</strong><strong>for</strong>mation to document the OTS software hazardanalysis:OTS <strong>Software</strong> <strong>Guidance</strong>, F<strong>in</strong>al page 7
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