The risk management tool for medical devices

Would you like to ...

  • be compliant to ISO 14971 -- Application of risk management to medical devices?
  • do risk analysis your way and not the way a tool prescribes it?
  • use pre-configured potential hazards from ISO 14971?
  • ensure that your mitigations are implemented?
  • see the effect of your mitigations in a pre and post mitigation risk summary?
  • be warned if you have incomplete risk coverage or umitigated risks?
  • spend less time on maintaining documents?

So why don't you start using Aligned Elements and reduce the time spent on risk management and overall traceability?

  • by easily tracing ISO 14971 risk controls / mitigations to your design inputs?
  • by automating checks for not implemented mitigations?
  • by checking the completeness of your risk management in seconds?
  • by re-using mitigations to save time and ensure consistency?
  • by using configurable (preliminary) hazard analyis and FMEA in a single tool?
  • by creating and updating your risk management files at the press of a button?

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Request your live online presentation of Aligned Elements now!