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Software IV&V

Software IV&V

IV&V Australia provide software verification and validation consulting to companies undertaking medical device developments in a regulatory environment. We provide support to project offices and prime contractors to help ensure that projects proceed to final acceptance in a systematic manner. That is, project milestones are met, deliverables are acceptable, and risks are effectively managed.

What is Software IV&V

  • IV&V stands for independent verification & validation
  • IV&V is the process of:
    • verifying that the output of each software phase meets its requirements, and
    • validating that the software, at the end of the development effort, meets the overall project objectives.

What can we do for you?

  • Strategic reviews: Review project plans and schedules (ie, development, test, management) to ensure that they are effective and are being followed.
  • Requirements tracing: Review requirements coverage to ensure that contractual requirements are being carried through to implementation and testing.
  • Document and process reviews: Review technical documentation to ensure completeness and appropriateness of design and test documentation and conformance with applicable standards.
  • Risk management: Review project processes and artefacts to identify risks and ensure that effective risk management is occurring.
  • Acquisition assistance: Develop acquisition risk management plans, provide subject matter expertise in design, development and test product evaluations, review test readiness data, and develop and run independent product tests.
  • Software strategy and product evaluation (Technical due diligence): Provide independent assessment of claims being made about development capability and/or products under development.


We provide specialised IV&V services to biomedical companies developing software-based systems, including:

  • Independent product evaluations
  • Software development capability reviews
  • Specification activities, including preparing software specifications and concept selection
  • Hazards analysis
  • Assistance with regulatory submissions
  • Commercialisation assistance

Click here to download an overview brochure.