V&V Remediation Support for Class III Device

Project Goals

Sunrise was asked to prepare a legacy product, including system architecture comprised of 20 software units, for regulatory submission to obtain a CE mark.

Sunrise Labs Solution

  • Reviewed existing software architecture, detailed design and implementation
  • Developed and documented verification test strategy including unit test protocols, with dynamic testing where possible and utilizing a trace matrix between the SRS, SDD and Unit Tests to ensure optimum test coverage
  • Executed unit testing per plan, including organizing and managing inspection reviews
  • Supported client’s Engineering and Regulatory affairs staff to prepare for regulatory submission


V&V Plans, Protocols and Reports were reviewed, approved and released into the client’s documentation control system in time for inclusion into the Design History File, allowing them to meet their regulatory submission schedule.

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